A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

AbbVie

Status and phase: Completed; Phase 3

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Placebo; Drug: Veliparib

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT02032277

2013-002377-21 (EudraCT Number)

M14-011

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Documented Breast Cancer Gene (BRCA) germline mutation testing.
3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
4. ECOG Performance status of 0 to 1.
5. 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.

Exclusion criteria

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
3. 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.
4. A history of seizure within 12 months prior to study entry.
5. Pre-existing neuropathy from any cause in excess of Grade 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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634 participants in 3 patient groups, including a placebo group

Arm A

Active Comparator group

Description:

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

Treatment:

Drug: Veliparib

Drug: Carboplatin

Drug: Paclitaxel

Drug: Doxorubicin

Drug: Cyclophosphamide

Arm C

Placebo Comparator group

Description:

Placebo + placebo + paclitaxel followed by AC.

Treatment:

Drug: Placebo

Drug: Paclitaxel

Drug: Placebo

Drug: Doxorubicin

Drug: Cyclophosphamide

Arm B

Placebo Comparator group

Description:

Placebo + carboplatin + paclitaxel followed by AC

Treatment:

Drug: Placebo

Drug: Carboplatin

Drug: Paclitaxel

Drug: Placebo

Drug: Doxorubicin

Drug: Cyclophosphamide