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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 August 2016
Main ID:  EUCTR2014-000345-70-FI
Date of registration: 20/05/2014
Prospective Registration: Yes
Primary sponsor: AbbVie Deutschland GmbH & Co. KG
Public title: A Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without ABT-888 in Metastatic or Locally Advanced Unresectable Breast Cancer
Scientific title: A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Date of first enrolment: 01/07/2014
Target sample size: 500
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000345-70
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belarus Belgium Canada Chile Colombia
Czech Republic Denmark Estonia Finland France Germany Hungary Israel
Italy Japan Korea, Republic of Latvia Lithuania Mexico Netherlands Norway
Poland Portugal Puerto Rico Romania Russian Federation Singapore South Africa Spain
Sweden Taiwan Turkey Ukraine United Kingdom United States
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd.
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
-Men and women = 18 years of age;
- Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic;
- Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent;
- Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation; Measurable or non-measurable (but radiologically evaluable) disease per RECIST version 1.1 on computed tomography (CT) scan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 335
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

Exclusion criteria:
- Received anticancer agent(s) or an investigational agent within 21days prior to C1D-2 or radiotherapy within 28 days prior to C1D-2;
- More than 2 prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease;
- More than one prior line of platinum therapy for breast cancer;
- Subjects who have progressed on platinum therapy or recurred within 12 months of platinum therapy will be excluded;
- Prior therapy with PARP inhibitors
- Prior taxane therapy administered for the treatment of metastatic breast cancer with exceptions (see protocol);
- Subjects with active brain metastases or leptomeningeal disease.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cancer [C04]
HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated mutation (BRCA1 and BRCA2) Breast Cancer
MedDRA version: 19.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Intervention(s)

Product Name: Veliparib 40 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Veliparib 50 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Veliparib 100 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Paclitaxel
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Trade Name: Carboplatin
Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575-94-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Secondary Objective: The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR), Progression Free Survival 2 (PFS2) and duration of overall response (DOR) in subjects treated with veliparib in combination with C/P versus subjects treated with placebo with C/P.
Timepoint(s) of evaluation of this end point: Progression-free Survival (PFS): will be evaluated according to radiographic progression per RECIST (version 1.1) determined by investigators and survival information (death). Radiologic tumor response and disease progression will be assessed by CT scan utilizing RECIST (version 1.1). Assessments will be performed at Screening, at 9-week intervals thereafter, and at the Final Visit, if not performed within the last 4 weeks.
Main Objective: The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and in Her-2 Negative Metastatic or Locally Advanced Unresectable Breast Cancer
Primary end point(s): Progression Free Survival
Secondary Outcome(s)
Secondary end point(s): Clinical benefit rate (CBR)
Objective Response Rate (ORR)
Duration of Overall Response (DOR)
Overall Survival (OS)
PFS2
Timepoint(s) of evaluation of this end point: Clinical benefit rate, Objective Response Rate and Duration of Overall Response evaluated according to radiographic progression per RECIST (version 1.1) determined by investigators. Assessments will be performed at Screening, at 9-week intervals thereafter, and at the Final Visit.
Overall Survival (OS): will be evaluated according to survival information and post treatment information collected every 2 months beginning on the date the subject is registered off study and until the endpoint of death, the subject is lost to follow-up or until the study termination by AbbVie.
PFS2: will be evaluated according to survival information and post treatment information collected every 2 months.
Secondary ID(s)
M12-914
Source(s) of Monetary Support
AbbVie Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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