A Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without ABT-888 in Metastatic or Locally Advanced Unresectable Breast Cancer

Phase 1

• Conditions: HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated mutation (BRCA1 and BRCA2) Breast Cancer; MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000345-70-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-20
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified