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New hope for BRCA breast cancer: could cisplatin beat standard chemo?

NCT ID NCT01670500

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether cisplatin, a platinum-based chemo, works better than the standard doxorubicin/cyclophosphamide (AC) combo in women with newly diagnosed breast cancer who carry a BRCA mutation. 118 participants received either cisplatin or AC before surgery. The main goal was to see which treatment led to a higher rate of complete tumor disappearance (pathologic complete response).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cisplatin, Doxorubicin, Cyclophosphamide
What this could lead to
If cisplatin works better, it could offer a more effective chemotherapy option for women with BRCA-related breast cancer.
What could go wrong
This is a small Phase 2 trial, so results may not apply to all patients. Cisplatin also has side effects like kidney damage and nerve issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

118 people

The number who actually took part.

Start date

Oct 2012

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Georgetown University Medical Center

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

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Sibley Memorial Hospital

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

  • Smilow Cancer Hospital Care Center at Derby

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital Care Center at Guilford

    Guilford, Connecticut, 06437, United States

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.