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New chemo combo aims to shrink aggressive breast cancer before surgery

NCT ID NCT01525966

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This phase II trial is testing whether giving two chemotherapy drugs, carboplatin and nab-paclitaxel, before surgery can improve outcomes for people with locally advanced or inflammatory triple negative breast cancer. The goal is to see if this approach increases the rate of complete remission (no cancer left at surgery) from the historical 20% to 38%. About 67 participants will receive the drugs intravenously before their surgery.

What this could mean

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

Active substance
carboplatin and nab-paclitaxel (chemotherapy drugs)
What this could lead to
If this works, it could show that this chemotherapy combination before surgery helps more patients achieve complete remission, potentially reducing the need for extensive surgery.
What could go wrong
This is a phase II trial with only 67 participants, so results may not apply to all patients. Chemotherapy side effects like low blood counts and nerve damage are possible.

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

67 people

The number who actually took part.

Started

Feb 2012

Expected to finish

Nov 2026

An estimate. End dates often move.

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

19 years and older

Sex

Female participants only

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: * Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Tumor negative for expression of hormone receptors (\< 10%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing * Bilirubin =\< 1.5 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal * Alkaline phosphatase =\< 2 x upper limit of normal * Platelets \>= 100,000 cells/mm\^3 * Hemoglobin \> 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 * Creatinine =\< 1.5 mg/dL is recommended; however, institutional norms are acceptable * Left ventricular ejection fraction \> 50% * Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment * Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childbearing potential * All subjects must have the ability to understand and the willingness to sign a written informed consent * No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated \>= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria Exclusion Criteria: * Known active hepatitis B or C * Known active human immunodeficiency virus (HIV) * Prior breast cancer or other invasive malignancy treated within 5 years * Pregnancy * Neuropathy \> grade 1 * Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI) * Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • City of Hope- South Pasadena Cancer Center

    South Pasadena, California, 91030, United States

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