Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

NCT01670500 | Completed Phase 2 Results DMC

• 1 other identifier: 12-258
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 15

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.

Conditions

Breast Cancer

Keywords

germline mutation; BRCA1 mutation; BRCA2 mutation

Outcome Measures

Primary Outcomes (1)

• Rate of Pathologic Complete Response (pCR)

  Pathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms.

  3 years

Secondary Outcomes (4)

• Rate of Residual Cancer Burden (RCB) 0/1

  2 years

• Clinical Response Rate

  3 years

• Number of Grade 3 and Grade 4 Adverse Events

  2 years

• Analysis of Pre-chemotherapy Biopsies

  5 years

Study Arms (2)

Doxorubicin-Cyclophosphamide

ACTIVE COMPARATOR

Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4

Drug: Cyclophosphamide; Drug: Doxorubicin

Cisplatin

ACTIVE COMPARATOR

Cisplatin q 3 wk x 4

Drug: Cisplatin

Interventions

Cisplatin DRUG

administered intravenously every 3 weeks for 4 doses

Also known as: cisplatinum, or cis-diamminedichloroplatinum(II) (CDDP)

Cisplatin

Cyclophosphamide DRUG

administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses

Also known as: Cytoxan

Doxorubicin-Cyclophosphamide

Doxorubicin DRUG

administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses

Also known as: Adriamycin

Doxorubicin-Cyclophosphamide

Eligibility Criteria

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

You may qualify if:

• Pathologic confirmation of invasive breast cancer
• Stage: Clinical T1 \>/= 1.0 cm, T2 or T3, N0-3, M0
• HER2 negative
• ER and PgR status by immunohistochemistry must be known. ER positive patients are allowed if physicain has determined neoadjuvant chemo is appropriate.
• Life expectancy greater than six months
• Use of an effective means of contraception is required

You may not qualify if:

• Pregnant or breastfeeding
• Prior anthracycline or platinum based therapy
• Prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
• Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
• Peripheral neuropathy of any etiology that exceeds grade 1
• Significant hearing loss
• Renal dysfunction
• Use of other investigational or study agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
• Uncontrolled intercurrent illness
• Any condition that would prohibit administration of corticosteroids
• Uncontrolled diabetes
• Pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (unless not considered medically significant by the physician)
• Known HIV positive individuals on combination antiretroviral therapy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (15)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital Care Center at Derby

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center at Guilford

Guilford, Connecticut, 06437, United States

Location

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016-2698, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Takamizawa S, Ishiki H, Shimoi T, Shimizu M, Satomi E. Neoadjuvant Cisplatin in BRCA Carriers With HER2-Negative Breast Cancer. J Clin Oncol. 2020 Aug 10;38(23):2699-2700. doi: 10.1200/JCO.20.00789. Epub 2020 Jun 9. No abstract available.

  PMID: 32516091 DERIVED

• Tung N, Hacker MR, Garber JE. Reply to S. Takamizawa et al. J Clin Oncol. 2020 Aug 10;38(23):2700-2701. doi: 10.1200/JCO.20.01190. Epub 2020 Jun 9. No abstract available.

  PMID: 32516090 DERIVED

• Tung N, Arun B, Hacker MR, Hofstatter E, Toppmeyer DL, Isakoff SJ, Borges V, Legare RD, Isaacs C, Wolff AC, Marcom PK, Mayer EL, Lange PB, Goss AJ, Jenkins C, Krop IE, Winer EP, Schnitt SJ, Garber JE. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial). J Clin Oncol. 2020 May 10;38(14):1539-1548. doi: 10.1200/JCO.19.03292. Epub 2020 Feb 25.

  PMID: 32097092 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin; Cyclophosphamide; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Project Manager
• Organization: DFCI

CTOPM@dfci.harvard.edu

617-632-2257

Study Officials

• Nadine Tung, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 22, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: February 2, 2025
• Last Updated: May 5, 2026
• Results First Posted: August 3, 2020

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)