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Completed Phase 2 Interventional Results available

Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

ClinicalTrials.gov ID: NCT01670500

Public ClinicalTrials.gov record NCT01670500. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01670500
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
118 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2012
Primary completion
Apr 30, 2019
Completion
Feb 1, 2025
Last update posted
May 4, 2026

2012 – 2025

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
University of Colorado Cancer Center Aurora Colorado 80045
Smilow Cancer Hospital Care Center at Derby Derby Connecticut 06418
Smilow Cancer Hospital Care Center at Guilford Guilford Connecticut 06437
St. Francis Hospital and Medical Center Hartford Connecticut 06105
Yale School of Medicine New Haven Connecticut 06520
Georgetown University Medical Center Washington D.C. District of Columbia 20007
Sibley Memorial Hospital Washington D.C. District of Columbia 20016-2698
Johns Hopkins Baltimore Maryland 21287
Massachusetts General Hospital Boston Massachusetts 02114
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Dana-Farber Cancer Institute Boston Massachusetts 02215
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08901
Duke University Durham North Carolina 27708
Women and Infants Hospital Providence Rhode Island 02905
MD Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01670500, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 4, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01670500 live on ClinicalTrials.gov.

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