protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01192568 | 11.7.6 | Vision Symptom Questionnaire | 11.7.6 Vision Symptom Questionnaire Vision symptom questionnaire data will be summarized for the Post-Amendment 3 safety population by visit and by dose level for the open-label period. | [] |
NCT01192568 | 11.7.7 | R- and S-Oxybutynin and N-desethyloxybutynin Plasma Concentrations | 11.7.7 R- and S-Oxybutynin and N-desethyloxybutynin Plasma Concentrations Plasma concentration data for oxybutynin and DEO plasma concentrations for the R-isomer, S-isomer, and R+S as well as the ratio of DEO to oxybutynin will be summarized for the pharmacokinetic population by visit. Summaries will be provided overal... | [] |
NCT01192568 | 12 | DATA HANDLING AND RECORDKEEPING | 12 DATA HANDLING AND RECORDKEEPING Electronic case report forms (eCRFs) will be designed and supplied by the sponsor. The eCRFs represent a record of the patient's experience in the study. The data recorded in the eCRFs must be supported by original (or source) medical records, as appropriate. Data recorded directly on... | [] |
NCT01192568 | 12.1 | Data Generation and Analysis | 12.1 Data Generation and Analysis After the site personnel complete data entry, electronic error and logic checks will be conducted to identify missing, incorrect, and/or out-of-range values. Discrepancies will be resolved through the system. | [] |
NCT01192568 | 12.2 | Access to Source Documentation | 12.2 Access to Source Documentation The investigator agrees that the sponsor or its designated agents, the IRB, and the FDA or foreign regulatory agencies will have reasonable access to study source documentation for purposes of audit and review both during and after completion of the study. These monitoring visits pro... | [] |
NCT01192568 | 12.3 | Retention of Data | 12.3 Retention of Data In compliance with ICH guidelines, the investigator shall maintain adequate records for the study, including medical records, laboratory reports, consent forms, study treatment disposition records, safety reports, information regarding participants who discontinued, and other pertinent data. The ... | [] |
NCT01192568 | 13 | OTHER INFORMATION | 13 OTHER INFORMATION | [] |
NCT01192568 | 13.1 | Financing and Insurance | 13.1 Financing and Insurance Financing and insurance is addressed in a separate agreement. | [] |
NCT01192568 | 13.2 | Publication and Disclosure Policy | 13.2 Publication and Disclosure Policy Publication and disclosure policy is addressed in a separate agreement. | [] |
NCT01192568 | 13.3 | Termination of the Study | 13.3 Termination of the Study If the study is terminated prematurely or suspended, all the appropriate IRB and regulatory authority (ies) will be promptly informed of the termination or suspension and will be provided the reason(s) for the termination or suspension. All obligations and responsibilities of the sponsor a... | [] |
NCT01192568 | 14 | REFERENCE LIST | 14 REFERENCE LIST - 1. Caramelli KE, Staskin DR, Volinn W. Steady-state pharmacokinetics of an investigational oxybutynin topical gel in comparison with oxybutynin transdermal system. Poster presented at Annual Meeting of the American Urological Association. May 17-22, 2008, Orlando, FL. - 2. Caramelli KE, Thomas H, St... | [] |
NCT01192568 | 15 | APPENDICES | 15 APPENDICES | Appendix 1 | Schedule of Events | |------------|--------------------| |------------|--------------------| - Appendix 2 Clinical Laboratory Evaluations - Appendix 3 Sample 2-Day Urinary Diary - Appendix 4 Urodynamic Evaluation - Appendix 5 Anticholinergic Symptoms Questionnaire - Appendix 6 Vision Sympto... | [
"Appendix 1 Schedule of Events",
"Post-Amendment 3",
"Appendix 2 Clinical Laboratory Evaluations",
"Hematology (performed on whole blood)",
"Chemistry (performed on serum)",
"Other Labs (performed on urine)",
"Appendix 3 Sample 2-Day Urinary Diary",
"Instruction to Study Coordinator:",
"Instructions... |
NCT01271725 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT01271725 | 1.1 | MEDICAL BACKGROUND | 1.1 MEDICAL BACKGROUND Breast cancer is the most common malignant disease in women in the Western world. In the US, more than 200,000 women will be diagnosed with breast cancer every year, and approximately a fifth will eventually die of the disease [\(R09-5656\)](#page-78-1). Aberrant Epidermal Growth Factor Receptor ... | [] |
NCT01271725 | 1.2 | DRUG PROFILE | 1.2 DRUG PROFILE BIBW 2992 (afatinib) is a novel oral EGFR/HER2 inhibitor that offers the chance to control both recurrent as well as distant metastatic disease on an outpatient basis with continuous treatment. It is a potent, irreversible, combined EGFR/HER2 inhibitor both in vitro and in vivo1 . Receptor tyrosine kin... | [] |
NCT01271725 | 2 | RATIONALE, OBJECTIVES, AND BENEFIT - RISK ASSESSMENT | 2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK ASSESSMENT | [] |
NCT01271725 | 2.1 | RATIONALE FOR PERFORMING THE TRIAL | 2.1 RATIONALE FOR PERFORMING THE TRIAL Patients who received neo-adjuvant and/or adjuvant HER2-targeted treatment will be recruited into this trial. Trastuzumab is currently registered as HER2-targeted treatment in the adjuvant and 1st line metastatic setting in combination with chemotherapy and as monotherapy in later... | [] |
NCT01271725 | 2.2 | TRIAL OBJECTIVES | 2.2 TRIAL OBJECTIVES This open label phase II study will investigate the efficacy and safety of BIBW 2992 (afatinib) alone and in combination with weekly treatment with paclitaxel or vinorelbine (in patients who progress on BIBW 2992 (afatinib) monotherapy only) as a new treatment algorithm in patients with HER2-overex... | [] |
NCT01271725 | 2.3 | BENEFIT - RISK ASSESSMENT | 2.3 BENEFIT - RISK ASSESSMENT HER2-positive breast cancer still has a poor prognosis despite recent advances which came with the introduction of targeted trastuzumab treatment into therapy. Trastuzumab is a standard component of HER2 positive breast cancer treatment although its use is associated with cardiotoxicity. P... | [
"Furthermore a decision has been made to stop further enrolment of new patients in Part A:"
] |
NCT01271725 | 3 | DESCRIPTION OF DESIGN AND TRIAL POPULATION | 3. DESCRIPTION OF DESIGN AND TRIAL POPULATION | [] |
NCT01271725 | 3.1 | OVERALL TRIAL DESIGN AND PLAN | 3.1 OVERALL TRIAL DESIGN AND PLAN This is an open label study designed to investigate the efficacy and safety of BIBW 2992 (afatinib) alone and in combination with weekly paclitaxel or weekly vinorelbine as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in t... | [] |
NCT01271725 | 3.1.1 | Administrative structure of the trial | 3.1.1 Administrative structure of the trial The investigators participating in the trial must have experience in this type of trial and investigations. The co-ordinating investigator, who will sign the clinical trial report of this trial, has been appointed by Boehringer Ingelheim. The co-ordinating investigator has ex... | [] |
NCT01271725 | 3.2 | DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUP | 3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUP The primary objective of this trial is to investigate the efficacy and safety of BIBW 2992 (afatinib) alone and in combination with weekly treatment with paclitaxel or vinorelbine (in patients who progress on BIBW 2992 (afatinib) monotherapy only) as... | [] |
NCT01271725 | 3.3 | SELECTION OF TRIAL POPULATION | 3.3 SELECTION OF TRIAL POPULATION A log of all patients included into the study (i.e. having given informed consent) will be maintained in the ISF at the investigational site irrespective of whether they have been treated with investigational drug or not. | [] |
NCT01271725 | 3.3.1 | Main diagnosis for study entry | 3.3.1 Main diagnosis for study entry All patients that will be included into the trial must have been diagnosed with histologically confirmed HER2-overexpressing disease breast cancer and must have stage IV metastatic disease. | [] |
NCT01271725 | 3.3.2 | Inclusion criteria | 3.3.2 Inclusion criteria These inclusion criteria apply to both mono and combination therapy (Parts A and B)
Inclusion criteria for Part A [\(Flow Chart A](#page-7-1)) - 1. Female patients ≥18 years. - 2. Proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer. Patients must have an archived ti... | [
"Inclusion criteria for Part A [\\(Flow Chart A](#page-7-1))",
"Inclusion criteria for Part B [\\(Flow Chart B](#page-10-1)) – BIBW 2992 (afatinib) combination therapy with paclitaxel and vinorelbine only"
] |
NCT01271725 | 3.3.3 | Exclusion criteria | 3.3.3 Exclusion criteria These exclusion criteria apply to both monotherapy and combination therapy (Parts A and B)
Exclusion criteria for Part A – BIBW 2992 (afatinib) monotherapy only [\(See](#page-7-1) [Flow Chart A](#page-7-1)) 1. Requirement for treatment with any of the prohibited concomitant medications listed ... | [
"Exclusion criteria for Part A – BIBW 2992 (afatinib) monotherapy only [\\(See](#page-7-1) [Flow Chart A](#page-7-1))"
] |
NCT01271725 | 3.3.4 | Removal of patients from therapy or assessments | 3.3.4 Removal of patients from therapy or assessments | [] |
NCT01271725 | 3.3.4.1 | Removal of individual patients | 3.3.4.1 Removal of individual patients A patient has to be withdrawn from study therapy in case any of the following applies: - 1. The patient withdraws consent to further study treatment. - 2. Documented progressive disease (see [Appendix 3](#page-83-0)) on combination treatment of BIBW 2992 (afatinib) and paclitaxel/... | [] |
NCT01271725 | 3.3.4.2 | Discontinuation of the trial by the sponsor | 3.3.4.2 Discontinuation of the trial by the sponsor Boehringer Ingelheim reserves the right to discontinue the trial overall or at a particular trial site at any time for the following reasons: - 1. Failure to meet expected enrolment goals overall or at a particular trial site, - 2. Emergence of any efficacy/safety inf... | [] |
NCT01271725 | 4 | TREATMENTS | 4. TREATMENTS | [] |
NCT01271725 | 4.1 | TREATMENTS TO BE ADMINISTERED | 4.1 TREATMENTS TO BE ADMINISTERED Patients will initially be treated with BIBW 2992 (afatinib) 40mg/day monotherapy until 1st disease progression on trial. Upon the latter, patients will additionally receive either paclitaxel weekly at a dose of 80 mg/m2 or vinorelbine at a weekly dose of 25 mg/m2 ( See [section 3.1](#... | [] |
NCT01271725 | 4.1.1 | Identity of BI investigational product and comparator products | 4.1.1 Identity of BI investigational product and comparator products Substance (INN): BIBW 2992 (afatinib) Pharmaceutical form: Film-coated tablets Source: Boehringer Ingelheim Pharma GmbH & Co. KG Unit strength: 20mg, 30mg and 40mg film-coated tablets (the dose of BIBW 2992 (afatinib)) in the film-coated tablets is re... | [
"Substance (INN) Paclitaxel"
] |
NCT01271725 | 4.1.2 | Method of assigning patients to treatment groups | 4.1.2 Method of assigning patients to treatment groups All patients will initially receive first line monotherapy with BIBW 2992 (afatinib) until disease progression (With protocol amendment 6 the sponsor will stop recruitment into the trial (part A), pending approval by IRBs and IECs. (See [section 3.3.4.2](#page-34-0... | [] |
NCT01271725 | 4.1.3 | Selection of doses in the trial | 4.1.3 Selection of doses in the trial The Maximum Tolerated Dose (MTD) and recommended phase II dose for BIBW 2992 (afatinib) in combination with either paclitaxel 80 mg/m2 or vinorelbine 25 mg/m2 weekly was determined at 40 mg in a continuous regimen. The decision to administer weekly paclitaxel is based on publicatio... | [] |
NCT01271725 | 4.1.4 | Drug assignment and administration of doses for each patient | 4.1.4 Drug assignment and administration of doses for each patient For administrative purposes, treatment will be divided into treatment courses, which are each 3 weeks (21 days) in duration. Patients will take a single oral dose of 40 mg BIBW 2992 (afatinib) every day for the first course (21 days). The medication sho... | [
"Vinorelbine & Paclitaxel"
] |
NCT01271725 | 4.1.5 | Blinding and procedures for unblinding | 4.1.5 Blinding and procedures for unblinding | [] |
NCT01271725 | 4.1.5.1 | Blinding | 4.1.5.1 Blinding Not applicable in this trial. | [] |
NCT01271725 | 4.1.5.2 | Procedures for emergency unblinding | 4.1.5.2 Procedures for emergency unblinding Not applicable in this trial. | [] |
NCT01271725 | 4.1.6 | Packaging, labelling, and re-supply | 4.1.6 Packaging, labelling, and re-supply | [] |
NCT01271725 | 4.1.6.1 | BIBW 2992 (afatinib) | 4.1.6.1 BIBW 2992 (afatinib) BIBW 2992 (afatinib) will be supplied as film-coated tablets. Available dosage strengths will be 20mg, 30mg and 40mg. Tablets will be supplied in HDPE, a child-resistant, tamperevident bottles. Bottles will be labelled according to local regulations and will include the following as a minim... | [] |
NCT01271725 | 4.1.6.2 | Paclitaxel | 4.1.6.2 Paclitaxel Paclitaxel will be supplied as a vial containing 6mg/ml concentrate for solution for infusion. Vials/boxes will be labelled according to local regulations and will include the following as a minimum; - Study number (1200.98) - Product name (Paclitaxel) - Contents of the vial - Dose strength - Batch n... | [] |
NCT01271725 | 4.1.6.3 | Vinorelbine | 4.1.6.3 Vinorelbine Vinorelbine will be supplied as a vial containing 10mg/ml solution. This is a concentrate for the preparation of a solution for infusion. Vials/boxes will be labelled according to local regulations and will include the following as a minimum; - Study number (1200.98) - Product name (Vinorelbine) - C... | [] |
NCT01271725 | 4.1.7 | Storage conditions | 4.1.7 Storage conditions BIBW 2992 (afatinib) must be stored in the original packaging. Film-coated tablets are humidity sensitive and therefore bottles must be kept tightly closed. Tablets will be stored at the study site in a limited access area and must not be stored above 25ºC. Paclitaxel and vinorelbine will be st... | [] |
NCT01271725 | 4.1.8 | Drug accountability | 4.1.8 Drug accountability Drug supplies, which will be provided by Boehringer Ingelheim, must be kept in a secure, limited access storage area under the storage conditions defined by the sponsor. A temperature log must be maintained to make certain that the drug supplies are stored at the correct temperature. The inves... | [] |
NCT01271725 | 4.2 | CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE TREATMENT | 4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE TREATMENT | [] |
NCT01271725 | 4.2.1 | Rescue medication, emergency procedures, and additional treatments | 4.2.1 Rescue medication, emergency procedures, and additional treatments Symptomatic treatments of tumour-associated symptoms are allowed. Treatment with corticosteroids and bisphosphonates are allowed. Concomitant medications, or therapy to provide adequate care, may be given as clinically necessary. Restrictions in [... | [] |
NCT01271725 | 4.2.2 | Restrictions | 4.2.2 Restrictions | [] |
NCT01271725 | 4.2.2.1 | Restrictions regarding concomitant treatment | 4.2.2.1 Restrictions regarding concomitant treatment Patients should not receive any additional experimental anti-cancer treatment, chemotherapy, immunotherapy, hormone treatment, maintenance therapy for metastatic breast cancer or radiotherapy within 4 weeks (within 2 weeks for hormone treatment) prior to receiving tr... | [] |
NCT01271725 | 4.2.2.2 | Restrictions on diet and lifestyle | 4.2.2.2 Restrictions on diet and lifestyle
For BIBW 2992 (afatinib): In the event of diarrhoea, patients should be advised to avoid lactose-containing products or any foods known to aggravate diarrhoea. To prevent skin related adverse events: It is currently proactively recommended to avoid intense irradiation with UV... | [
"For BIBW 2992 (afatinib):",
"For paclitaxel:",
"For vinorelbine:"
] |
NCT01271725 | 4.2.2.5 | Management of rash following treatment with BIBW 2992 (afatinib) | 4.2.2.5 Management of rash following treatment with BIBW 2992 (afatinib) A proactive and early approach to management of rash is crucial. Rash can be managed by a variety of treatment options to relieve symptoms and reduce the rash. The recommendations for management are as follows: - General/Prevention: see [Section 4... | [] |
NCT01271725 | 4.3 | TREATMENT COMPLIANCE | 4.3 TREATMENT COMPLIANCE Study medications will be given in accordance with the protocol and under the instruction of the site investigator. | [] |
NCT01271725 | 4.3.1 | BIBW 2992 (afatinib) | 4.3.1 BIBW 2992 (afatinib) BIBW 2992 (afatinib): Patients treated with BIBW 2992 (afatinib) should take the first dose of BIBW 2992 (afatinib) treatment at the trial site and subsequent doses will be taken at home. A compliance check of trial medication should be performed on Day 15 of Treatment Course 1 and Day 1 of e... | [] |
NCT01271725 | 5 | VARIABLES AND THEIR ASSESSMENT | 5. VARIABLES AND THEIR ASSESSMENT | [] |
NCT01271725 | 5.1 | EFFICACY - CLINICAL PHARMACOLOGY OR PHARMACODYNAMICS | 5.1 EFFICACY - CLINICAL PHARMACOLOGY OR PHARMACODYNAMICS | [] |
NCT01271725 | 5.1.1 | Endpoints of efficacy | 5.1.1 Endpoints of efficacy | [] |
NCT01271725 | 5.1.1.1 | Primary endpoint | 5.1.1.1 Primary endpoint The primary endpoint of this study for BIBW 2992 (afatinib) monotherapy and combination therapy is: - Objective Response (OR) assessed by RECIST 1.1 | [] |
NCT01271725 | 5.1.1.2 | Secondary endpoints | 5.1.1.2 Secondary endpoints The secondary endpoints for this study are: - Best overall response during each treatment period according to RECIST 1.1 - Duration of objective response, defined as the time from first objective response to the time of progression or death. - Progression-Free Survival (PFS) will be defined ... | [] |
NCT01271725 | 5.1.2 | Assessment of efficacy | 5.1.2 Assessment of efficacy Efficacy will be evaluated according to RECIST 1.1 [\(R09-0262](#page-77-10)). Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) will be assessed by the investigator (Ref[: Appendix 3](#page-83-0) for RECIST 1.1 criteria) Every effort should be m... | [] |
NCT01271725 | 5.2 | SAFETY | 5.2 SAFETY | [] |
NCT01271725 | 5.2.1 | Endpoints of safety | 5.2.1 Endpoints of safety Safety of BIBW 2992 (afatinib), paclitaxel and vinorelbine will be evaluated as indicated by intensity and incidence of adverse events, graded according to US NCI CTCAE Version 3.0 ([R04-0474](#page-76-9)). Safety endpoints include: - Events leading to permanent dose reduction - Events leading... | [] |
NCT01271725 | 5.2.2 | Assessment of adverse events | 5.2.2 Assessment of adverse events | [] |
NCT01271725 | 5.2.2.1 | Definitions of adverse events | 5.2.2.1 Definitions of adverse events
Adverse event An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationsh... | [
"Adverse event",
"Serious adverse event",
"Intensity of adverse event",
"Causal relationship of adverse event",
"Planned Hospitalizations",
"Protocol-specified significant events"
] |
NCT01271725 | 5.2.2.2 | Adverse event and serious adverse event reporting | 5.2.2.2 Adverse event and serious adverse event reporting All adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the observational phase) will be collected, documented and reported to the sponsor by the investigator on the ... | [
"Pregnancy"
] |
NCT01271725 | 5.2.3 | Assessment of safety laboratory parameters | 5.2.3 Assessment of safety laboratory parameters Blood samples will be collected at the time points specified in [Flow Chart A](#page-7-1) and [Flow Chart](#page-10-1) [B](#page-10-1) and analysed in a laboratory facility at or close to the investigational site. Safety laboratory examinations include haematology and bi... | [] |
NCT01271725 | 5.2.4 | Electrocardiogram | 5.2.4 Electrocardiogram A standard 12-lead resting ECG will be performed at the time-points specified in [Flow Chart](#page-7-1) [A](#page-7-1) and [Flow Chart B](#page-10-1) i.e. at Screening, on Day 15 of Monotherapy Course 1, on Day 1 of every third monotherapy course (i.e. Day 1 of Course 4, 7, 10 etc.), on Day 1 o... | [] |
NCT01271725 | 5.2.5 | Assessment of other safety parameters | 5.2.5 Assessment of other safety parameters | [] |
NCT01271725 | 5.2.5.1 | Physical examination, ECOG performance score | 5.2.5.1 Physical examination, ECOG performance score A physical examination will be performed at screening and at the time points specified in Flow Chart A and Flow Chart B. A full physical examination serves as a clinical tumour assessment and should include a cardiopulmonary examination, examination of the regional l... | [] |
NCT01271725 | 5.2.5.2 | Left ventricular function | 5.2.5.2 Left ventricular function Left Ventricular Ejection Fraction (LVEF) as measured by echocardiography or Multi Gated Acquisition Scan (MUGA) will be assessed at time points specified in the Flow Chart. The same method of measurement must be used throughout the study. Echocardiography (ECHO): Echocardiography will... | [] |
NCT01271725 | 5.2.5.3 | Vital signs | 5.2.5.3 Vital signs Vital signs (blood pressure and pulse after 2 minutes supine rest) and temperature will be recorded at the screening visit and at the time points specified in the [Flow Chart A](#page-7-1) and [Flow](#page-10-1) [Chart B.](#page-10-1) | [] |
NCT01271725 | 5.3 | OTHER | 5.3 OTHER  | [] |
NCT01271725 | 5.3.2 | Other assessments | 5.3.2 Other assessments Not applicable to this protocol | [] |
NCT01271725 | 5.3.3 | Pharmacogenomic evaluation | 5.3.3 Pharmacogenomic evaluation No pharmacogenomic evaluation is planned in this protocol | [] |
NCT01271725 | 5.4 | APPROPRIATENESS OF MEASUREMENTS | 5.4 APPROPRIATENESS OF MEASUREMENTS The RECIST criteria 1.1 [\(R09-0262](#page-77-10)) to be used for evaluation of tumour response are well established and scientifically accepted. The US NCI CTCAE criteria version 3.0 [\(R04-0474](#page-76-9)) are used in the assessment of adverse events. | [] |
NCT01271725 | 5.5 | DRUG CONCENTRATION MEASUREMENTS AND PHARMACOKINETICS | 5.5 DRUG CONCENTRATION MEASUREMENTS AND PHARMACOKINETICS Not applicable to this protocol | [] |
NCT01271725 | 5.5.1 | Pharmacokinetic endpoints | 5.5.1 Pharmacokinetic endpoints Not applicable to this protocol | [] |
NCT01271725 | 5.5.2 | Methods of sample collection | 5.5.2 Methods of sample collection Not applicable to this protocol | [] |
NCT01271725 | 5.5.3 | Analytical determinations | 5.5.3 Analytical determinations Not applicable to this protocol | [] |
NCT01271725 | 5.6 | BIOMARKERS | 5.6 BIOMARKERS There will be no on-trial biopsies. All biomarker evaluations will be used to retrospectively confirm the patient's HER2/hormone receptor status and are performed on archival tissue samples. The results of these tests are not required to confirm the patients' eligibility to take part in the study.
Archi... | [
"Archived tissue:"
] |
NCT01271725 | 5.6.1 | Endpoints based on biomarkers | 5.6.1 Endpoints based on biomarkers There are no clinical trial endpoints based on biomarkers. | [] |
NCT01271725 | 5.6.2 | Methods of sample collection | 5.6.2 Methods of sample collection The FFPE tumour slides (minimum of 10 slides) from the primary tumour or metastasis should be provided and sent to the central laboratory for retesting to confirm the patient's HER2 status. This is not required for screen failures. The following tests will be done: - HER2 IHC and refl... | [] |
NCT01271725 | 5.6.3 | Analytical determinations | 5.6.3 Analytical determinations HER2 IHC/FISH, HrR IHC and Allred, will be performed according to standard procedures by the central lab. Details to be provided in the laboratory manual in the ISF. | [] |
NCT01271725 | 5.7 | PHARMACODYNAMICS | 5.7 PHARMACODYNAMICS | [] |
NCT01271725 | 5.7.1 | Pharmacodynamic endpoints | 5.7.1 Pharmacodynamic endpoints No pharmacodynamic endpoints planned | [] |
NCT01271725 | 5.7.2 | Methods of sample collection | 5.7.2 Methods of sample collection Not applicable to this protocol | [] |
NCT01271725 | 5.8 | PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP | 5.8 PHARMACOKINETIC - PHARMACODYNAMIC RELATIONSHIP Not applicable to this protocol | [] |
NCT01271725 | 6 | INVESTIGATIONAL PLAN | 6. INVESTIGATIONAL PLAN | [] |
NCT01271725 | 6.1 | VISIT SCHEDULE | 6.1 VISIT SCHEDULE This is an open-label study in patients with metastatic breast cancer. Patients meeting the inclusion and exclusion criteria and who have given their written informed consent are eligible for participation in the study. | [] |
NCT01271725 | 6.2 | DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS | 6.2 DETAILS OF TRIAL PROCEDURES AT SELECTED VISITS Written informed consent must be obtained before any protocol specific screening assessments are performed. A treatment course lasts 21 days. Visit 1 takes place on the first day of each treatment course and will occur on the day after the preceding 21 day course. For ... | [] |
NCT01271725 | 6.2.1 | Screening and run-in period(s) (Up to 14 days before start of treatment) | 6.2.1 Screening and run-in period(s) (Up to 14 days before start of treatment) Refer to [Flow Chart A](#page-7-1). All patients who signed the written informed consent before the approval of amendment 6 by IRBs and IECs (See [section 3.3.4.2](#page-34-0) and [section 11](#page-88-0)) may continue in the trial- After ap... | [] |
NCT01271725 | 6.2.2 | Treatment periods | 6.2.2 Treatment periods
Course 1, Visit 1, Day 1 (Visit C1V1) Refer to [Flow Chart A](#page-7-1) - (BIBW 2992 (afatinib) monotherapy) Assessments to complete at this visit: - Confirm patient eligibility - Limited physical examination including measurement of body weight - Vital signs - Performance status (ECOG scale) ... | [
"Course 1, Visit 1, Day 1 (Visit C1V1)",
"Course 1, Visit 2, Day 15 (± 2 days) (Visit C1V2)",
"Treatment Course 2 (C2V1) and all subsequent treatment courses (CnVn) with BIBW 2992 (afatinib) Monotherapy",
"Visit VPC1V1 - Day 1(± 2 days)",
"Visit VPC1V2 - Day 8 (± 2 days)",
"Visit VPC1V3 - Day 15 (± 2 days... |
NCT01271725 | 6.2.3 | End of trial and follow-up period | 6.2.3 End of trial and follow-up period All patients should have an EOT visit when trial medication is permanently discontinued. Assessments to be performed at the EOT Visit are described below. End of Treatment Visit (EOT) - 0-14 days after permanent discontinuation of BIBW 2992 (afatinib) monotherapy or combination t... | [
"Additional Follow-Up Visit (where applicable) (FU Vn – every 6 weeks)"
] |
NCT01271725 | 7 | STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | 7. STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | [] |
NCT01271725 | 7.1 | STATISTICAL DESIGN - MODEL | 7.1 STATISTICAL DESIGN - MODEL The trial will be performed as a single arm open label study. Patients will receive BIBW 2992 (afatinib) monotherapy until disease progression according to RECIST 1.1. Afterwards they will be treated with BIBW 2992 (afatinib) in combination with either paclitaxel or vinorelbine until a fu... | [] |
NCT01271725 | 7.2 | NULL AND ALTERNATIVE HYPOTHESES | 7.2 NULL AND ALTERNATIVE HYPOTHESES All analyses in this study are descriptive and exploratory by nature. Any statistical tests are performed only to provide a statistical framework from which to view the results and providing aid for planning further studies. No formal statistical inferences are foreseen. | [] |
NCT01271725 | 7.3 | PLANNED ANALYSES | 7.3 PLANNED ANALYSES Treated analysis sets (TRT) are defined for mono- and combination-therapy separately. The TRT for monotherapy comprises all patients who received at least one single dose of BIBW 2992 (afatinib), and the TRT for combination therapy comprises all patients who received at least one dose each of BIBW ... | [] |
NCT01271725 | 7.3.1 | Primary analyses | 7.3.1 Primary analyses
Objective Response The primary analysis will estimate the proportion of patients who achieve objective response according to the RECIST 1.1 criteria for mono- and combination therapy separately. The individual response criteria will be relative to the respective baselines in each part and the ra... | [
"Objective Response"
] |
NCT01271725 | 7.3.2 | Secondary analyses | 7.3.2 Secondary analyses None of the secondary endpoints which use RECIST 1.1 require confirmation. | [] |
NCT01271725 | 7.3.2.1 | Key secondary analyses | 7.3.2.1 Key secondary analyses
Best overall response Frequency tables will be presented for the best RECIST assessment achieved by each patient during each of the treatment periods in the order (from best to worst): complete response, partial response, stable disease, disease progression.
Duration of objective respon... | [
"Best overall response",
"Duration of objective response",
"Progression-free survival"
] |
NCT01271725 | 7.3.4 | Interim analyses | 7.3.4 Interim analyses | [] |
Subsets and Splits
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