A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

AbbVie158 个研究点分布在 1 个国家目标入组 634 人开始时间: 2014年4月2日最近更新: 2021年1月20日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 634
试验地点: 158
主要终点: Pathological Complete Response (pCR).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 99 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
•Documented Breast Cancer Gene (BRCA) germline mutation testing.
•Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
•ECOG Performance status of 0 to
•Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

排除标准

•Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
•Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
•Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
•A history of seizure within 12 months prior to study entry.
•Pre-existing neuropathy from any cause in excess of Grade 1.

研究组 & 干预措施

Arm C

Placebo Comparator

Placebo + placebo + paclitaxel followed by AC.

干预措施: Placebo (Drug)

Arm C

Placebo Comparator

Placebo + placebo + paclitaxel followed by AC.

干预措施: Doxorubicin (Drug)

Arm A

Active Comparator

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

干预措施: Cyclophosphamide (Drug)

Arm A

Active Comparator

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

干预措施: Doxorubicin (Drug)

Arm A

Active Comparator

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

干预措施: Paclitaxel (Drug)

Arm A

Active Comparator

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

干预措施: Carboplatin (Drug)

Arm A

Active Comparator

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

干预措施: Veliparib (Drug)

Arm C

Placebo Comparator

Placebo + placebo + paclitaxel followed by AC.

干预措施: Cyclophosphamide (Drug)

Arm C

Placebo Comparator

Placebo + placebo + paclitaxel followed by AC.

干预措施: Paclitaxel (Drug)