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New drug cocktail shows promise against aggressive breast cancer

NCT ID NCT01796197

Disease control Sponsor: Dana-Farber Cancer Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of chemotherapy (paclitaxel) and two targeted antibodies (trastuzumab and pertuzumab) given before mastectomy to 23 women with HER2-positive inflammatory breast cancer. The goal was to see if the treatment could wipe out all cancer in the breast and lymph nodes by the time of surgery. Results showed that some women had a complete response, meaning no cancer remained, and the approach may help lower the chance of recurrence.

What this could mean

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

Active substance
Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin, Cyclophosphamide
What this could lead to
If successful, this combination could improve the chance of eliminating all cancer before surgery and reduce the risk of the cancer coming back.
What could go wrong
This is a small, early-phase trial with only 23 participants. The drugs may cause side effects like heart problems, and the results may not apply to all patients.

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

23 people

The number who actually took part.

Started

Aug 2013

Finished

Jan 2026

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: * Histologically confirmed invasive breast cancer * HER2 positive breast cancer * Clinical diagnosis of inflammatory breast cancer * Without evidence of visceral or bone involvement with metastatic cancer on physical exam or any diagnostic study. Extensive nodal involvement is allowed * Willingness to undergo a research biopsy of the affected breast Exclusion Criteria: * Prior therapy for the treatment of breast cancer * Receiving any other investigational or commercial agents or therapies * Known brain metastases * Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest * History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, trastuzumab, pertuzumab * Uncontrolled intercurrent illness * Pregnant or breastfeeding * History of a different malignancy except for the following circumstances: disease-free for at least 5 years and at low risk of recurrence, or cervical cancer in situ or basal or squamous cell carcinoma of the skin * HIV positive on combination anti-retroviral therapy

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm inflammatory breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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