A Study of (a) Veliparib and Temozolomide or (b) Veliparib, Carboplatin and Paclitaxel or (c) Placebo, Carboplatin and Paclitaxel in patients with Breast Cancer

Phase 1

• Conditions: BRCA1 or BRCA2 mutation metastatic breast cancer; MedDRA version: 15.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002913-12-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KGKG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-12
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
Must have a documented deleterious BRCA1 or BRCA2 germline mutation. The investigator should ensure that the testing is consistent with local guidelines, and clinical practice, and that the test uses either 1) direct DNA sequencing/multiplex ligation-dependent probe amplification (MLPA) or 2) a well-characterized methodology previously validated by sequencing, such as that used to assess founder mutations. If testing has been performed by a laboratory other than Sponsor core laboratory, subjects may be enrolled and must be re-tested by Sponsor core laboratory for confirmation of BRCA1 or BRCA2 germline mutations.
If HER2 positive (HER2 3+ by immunohistochemistry or amplification by fluorescence in situ hybridization [FISH > 2]), subjects must have received and progressed on at least one prior standard HER2-directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
Measurable lesion by RECIST (version 1.1) on computed tomography (CT) scan (within 21 days of C1D1) in at least one site. If only a single measurable lesion exists, it cannot be a bone or cystic lesion. Bone-only, lymphangitic pulmonary metastases, and previously irradiated tumors will be considered nonmeasurable.
ECOG Performance status of 0 to 2.
Adequate hematologic, renal, and hepatic function
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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Received anticancer agent(s), an investigational agent, or radiotherapy within 28days or 5 half lives; whichever is shorter, prior to C1D1. Prior treatment with palliative local breast or bone lesion radiation (other than pelvis) can occur within 14 days of C1D1. Subjects experiencing a significant adverse effect or toxicity (Grade 3 or Grade 4), causally attributed to previous anticancer treatment that has not recovered to at least Grade 2 are excluded. Anticancer hormonal therapy must be stopped 7 days prior to C1D1. Subjects receiving bisphosphonates are eligible.
More than 1 prior line of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease. Regimens received in the adjuvant/neoadjuvant setting within the past 6 months will also be considered toward the maximum of 1 prior line of therapy. In order to count as a line of therapy, a cytotoxic agent must have been administered for at least 1 full cycle. Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., trastuzumab lapatinib, erlotinib, gefitinib, bevacizumab) are allowed and are not counted towards the prior line of therapy.
Prior therapy with temozolomide, a platinum agent, or a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
Prior taxane therapy for metastatic disease. Use of taxanes as adjuvant therapy is permitted, if given more than 6 months prior to C1D1.
A history of or evidence of brain metastases or leptomeningeal disease. Subjects with symptoms to suggest central nervous system (CNS) metastases should have a brain MRI within 21 days of enrollment to confirm the absence of CNS metastases. Contrast CT is acceptable for subjects who are unable to undergo a brain MRI.
A history of uncontrolled seizure disorder.
Pre-existing neuropathy from any cause in excess of Grade 1.
Known history of allergic reactions to cremophor-paclitaxel.
Clinically significant uncontrolled condition(s).

Study & Design

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