Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer

NCT01818063 | Completed Phase 2 Results DMC

• 3 other identifiers: 12G.3762012-47JT 2997
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized phase II trial studies how well carboplatin and combination chemotherapy with or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and combination chemotherapy are more effective with or without veliparib is more effective in treating breast cancer.

Conditions

Estrogen Receptor-negative Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Count of Participants That Achieve Pathologic Complete Response (PCR)

  PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H\&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.

  36 months following surgery

Secondary Outcomes (2)

• Overall Clinical Response

  Up to 3 years

• Relapse Free Survival

  Up to 3 years

Study Arms (2)

Arm 1 (paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: Paclitaxel; Drug: Carboplatin; Drug: Doxorubicin; Drug: Cyclophosphamide

Arm 2 (veliparib, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

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

Interventions

Paclitaxel DRUG

Given IV

Also known as: Taxol, Abraxane

Arm 1 (paclitaxel, carboplatin); Arm 2 (veliparib, paclitaxel, carboplatin)

Carboplatin DRUG

Given IV

Also known as: cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II), Paraplatin, Paraplatin-AQ

Arm 1 (paclitaxel, carboplatin); Arm 2 (veliparib, paclitaxel, carboplatin)

Doxorubicin DRUG

Given IV

Also known as: Adriamycin, hydroxydaunorubicin, Adriamycin PFS, Adriamycin RDF, Rubex, Doxil

Arm 1 (paclitaxel, carboplatin); Arm 2 (veliparib, paclitaxel, carboplatin)

Cyclophosphamide DRUG

Given IV

Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune, cytophosphane, Lyophilizedcytoxan

Arm 1 (paclitaxel, carboplatin); Arm 2 (veliparib, paclitaxel, carboplatin)

Veliparib DRUG

Given PO

Also known as: ABT-888

Arm 2 (veliparib, paclitaxel, carboplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained prior to any study-related procedures.
• Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (\<1%), progesterone receptor negative (\<1%), and Her-2/neu negative (Her-2/neu 0-1+ IHC or FISH ratio \<1.8 or average HER2 gene copy number of \<four signal/nucleus for test systems without internal control probe).
• Female ≥ 18 years old.
• Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.
• Complete radiology or tumor assessment within 28 days prior to enrollment
• Breast MRI
• Unilateral Breast Ultrasound
• Distant metastatic work-up completed with PET/CT.
• If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.
• If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.
• ECOG Performance Status of 0 or 1
• Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:
• Cardiac Ejection Fraction \>/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.
• Hematologic function, as follows: Absolute neutrophil count ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L, Hemoglobin ≥ 9 g/dL, PTT and INR \< 1.5 x ULN.
• Renal function, as follows: Serum creatinine \</= 1.4 mg/dL).

You may not qualify if:

• Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, cremophor or medications containing cremophor(miconazole, docetaxel, sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, aci-jel) or carboplatin.
• Known HIV or active Hepatitis B or C infection.
• Prior treatment for the currently diagnosed breast cancer.
• Prior treatment with doxorubicin up to 400 mg/m2.
• Pre-existing Grade 3 or 4 sensory neuropathy.
• History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.
• Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).
• Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.
• Non-healing wound, ulcer or fracture.
• Ongoing or active infection.
• Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
• Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence. Contraception must be used during the study.
• T0 tumors
• Active dental infection

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (3)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Reading Hospital

Reading, Pennsylvania, 19611, United States

Location

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Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; liposomal doxorubicin; Cyclophosphamide; veliparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Edith Mitchell
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

edith.mitchell@jefferson.edu

215-955-8874

Study Officials

• Edith Mitchell, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: April 25, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 10, 2018
• Last Updated: April 30, 2025
• Results First Posted: January 16, 2018

Record last verified: 2025-04

Locations

US (3)