Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
NCT ID: NCT01818063
Last Updated: 2025-04-30
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-04-25
Study Completion Date
2018-12-10
Brief Summary
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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.
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Detailed Description
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PRIMARY OBJECTIVE:
1\) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.
SECONDARY OBJECTIVES:
1. Relapse free survival (follow-up period of 36 months).
2. Overall clinical response to neoadjuvant therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (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.
ARM II: Patients receive veliparib orally (PO) twice daily (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.
After completion of study treatment, patients are followed up every 3 months for 36 months.
1\) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.
SECONDARY OBJECTIVES:
1. Relapse free survival (follow-up period of 36 months).
2. Overall clinical response to neoadjuvant therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (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.
ARM II: Patients receive veliparib orally (PO) twice daily (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.
After completion of study treatment, patients are followed up every 3 months for 36 months.
Conditions
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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
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm 1 (paclitaxel, carboplatin)
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.
Group Type
EXPERIMENTAL
Paclitaxel
Intervention Type
DRUG
Given IV
Carboplatin
Intervention Type
DRUG
Given IV
Doxorubicin
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Arm 2 (veliparib, paclitaxel, carboplatin)
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.
Group Type
EXPERIMENTAL
Paclitaxel
Intervention Type
DRUG
Given IV
Carboplatin
Intervention Type
DRUG
Given IV
Doxorubicin
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Veliparib
Intervention Type
DRUG
Given PO
Interventions
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Paclitaxel
Given IV
Intervention Type
DRUG
Carboplatin
Given IV
Intervention Type
DRUG
Doxorubicin
Given IV
Intervention Type
DRUG
Cyclophosphamide
Given IV
Intervention Type
DRUG
Veliparib
Given PO
Intervention Type
DRUG
Other Intervention Names
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Taxol
Abraxane
cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)
Paraplatin
Paraplatin-AQ
Adriamycin
hydroxydaunorubicin
Adriamycin PFS
Adriamycin RDF
Rubex
Doxil
Endoxan
Cytoxan
Neosar
Procytox
Revimmune
cytophosphane
Lyophilizedcytoxan
ABT-888
Eligibility Criteria
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Inclusion Criteria
1. Written informed consent must be obtained prior to any study-related procedures.
2. 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).
3. Female ≥ 18 years old.
4. Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.
5. Complete radiology or tumor assessment within 28 days prior to enrollment
1. Breast MRI
2. Unilateral Breast Ultrasound
3. Distant metastatic work-up completed with PET/CT.
4. If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.
5. If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.
6. ECOG Performance Status of 0 or 1
7. Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:
1. Cardiac Ejection Fraction \>/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.
2. 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.
3. Renal function, as follows: Serum creatinine \</= 1.4 mg/dL).
4. Hepatic function, as follows:Aspartate aminotransferase (AST) ≤ 2.5 x ULN, Alanine aminotransferase (ALT) ≤ 2.5 x ULN , Total bilirubin ≤ 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin \< 3 ULN).
8. Patient must be willing and able to undergo MRI as outlined in protocol.
2. 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).
3. Female ≥ 18 years old.
4. Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.
5. Complete radiology or tumor assessment within 28 days prior to enrollment
1. Breast MRI
2. Unilateral Breast Ultrasound
3. Distant metastatic work-up completed with PET/CT.
4. If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.
5. If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.
6. ECOG Performance Status of 0 or 1
7. Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:
1. Cardiac Ejection Fraction \>/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.
2. 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.
3. Renal function, as follows: Serum creatinine \</= 1.4 mg/dL).
4. Hepatic function, as follows:Aspartate aminotransferase (AST) ≤ 2.5 x ULN, Alanine aminotransferase (ALT) ≤ 2.5 x ULN , Total bilirubin ≤ 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin \< 3 ULN).
8. Patient must be willing and able to undergo MRI as outlined in protocol.
Exclusion Criteria
1. 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.
2. Known HIV or active Hepatitis B or C infection.
3. Prior treatment for the currently diagnosed breast cancer.
4. Prior treatment with doxorubicin up to 400 mg/m2.
5. Pre-existing Grade 3 or 4 sensory neuropathy.
6. History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.
7. Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).
8. 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.
9. Non-healing wound, ulcer or fracture.
10. Ongoing or active infection.
11. Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
12. 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.
13. T0 tumors
14. Active dental infection
2. Known HIV or active Hepatitis B or C infection.
3. Prior treatment for the currently diagnosed breast cancer.
4. Prior treatment with doxorubicin up to 400 mg/m2.
5. Pre-existing Grade 3 or 4 sensory neuropathy.
6. History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.
7. Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).
8. 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.
9. Non-healing wound, ulcer or fracture.
10. Ongoing or active infection.
11. Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
12. 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.
13. T0 tumors
14. Active dental infection
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Susan G. Komen Breast Cancer Foundation
OTHER
Sponsor Role
collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Edith Mitchell, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Site Status
Reading Hospital
Reading, Pennsylvania, United States
Site Status
Countries
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United States
References
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Ruckhaberle E, Karn T, Engels K, Turley H, Hanker L, Muller V, Schmidt M, Ahr A, Gaetje R, Holtrich U, Kaufmann M, Rody A. Prognostic impact of thymidine phosphorylase expression in breast cancer--comparison of microarray and immunohistochemical data. Eur J Cancer. 2010 Feb;46(3):549-57. doi: 10.1016/j.ejca.2009.11.020. Epub 2009 Dec 18.
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BACKGROUND
Palacios J, Honrado E, Osorio A, Cazorla A, Sarrio D, Barroso A, Rodriguez S, Cigudosa JC, Diez O, Alonso C, Lerma E, Dopazo J, Rivas C, Benitez J. Phenotypic characterization of BRCA1 and BRCA2 tumors based in a tissue microarray study with 37 immunohistochemical markers. Breast Cancer Res Treat. 2005 Mar;90(1):5-14. doi: 10.1007/s10549-004-1536-0.
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BACKGROUND
Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010 Jun;134(6):907-22. doi: 10.5858/134.6.907.
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BACKGROUND
Vance GH, Barry TS, Bloom KJ, Fitzgibbons PL, Hicks DG, Jenkins RB, Persons DL, Tubbs RR, Hammond ME; College of American Pathologists. Genetic heterogeneity in HER2 testing in breast cancer: panel summary and guidelines. Arch Pathol Lab Med. 2009 Apr;133(4):611-2. doi: 10.5858/133.4.611.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.JeffersonHospital.org
Thomas Jefferson University Hospitals
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-47
Identifier Type: OTHER
Identifier Source: secondary_id
JT 2997
Identifier Type: OTHER
Identifier Source: secondary_id
12G.376
Identifier Type: -
Identifier Source: org_study_id
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