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Breast cancer trial aims to match drugs to tumors for personalized care

NCT ID NCT01042379

Knowledge-focused Sponsor: QuantumLeap Healthcare Collaborative Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing new drug combinations for breast cancer to see which ones work best for different tumor types. It involves up to 5,000 people with early-stage or locally advanced breast cancer. Researchers use MRI scans and tissue samples before surgery to predict treatment success and personalize care.

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

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2010

Expected to finish

Dec 2031

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

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 cancer of the breast * Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm) * No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed * Age ≥18 years * ECOG performance status 0-1 * Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers * Non-pregnant and non-lactating * No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible. * Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent) * Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis * Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F * Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \< 1.5 x institutional ULN * No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50% * No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase * Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™) * Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2) Exclusion Criteria: * Use of any other investigational agents within 30 days of starting study treatment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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Conditions

The condition(s) this trial relates to.

angiosarcoma breast cancer breast neoplasm HER2 positive breast carcinoma Her2-receptor negative breast cancer neoplasm Pathologic Complete Response triple-negative breast carcinoma

As listed by the trial registrant

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

Angiosarcoma Breast cancer Breast neoplasms Breast tumors Early-stage breast cancer HER2-negative breast cancer HER2-positive breast cancer Hormone receptor negative tumor Hormone receptor positive tumor Locally advanced breast cancer TNBC - triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    33 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Georgetown University Medical Center

    RECRUITING

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

  • H. Lee Moffitt Cancer Center and Research Institute

    RECRUITING

    Tampa, Florida, 33612, United States

  • HOAG Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Herbert-Herman Cancer Center, Sparrow Hospital

    RECRUITING

    Lansing, Michigan, 48912, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Inova Health System

    ACTIVE_NOT_RECRUITING

    Falls Church, Virginia, 22042, United States

  • Laura and Isaac Perlmutter Cancer Center / NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Loyola University

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic - Scottsdale

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Oregon Health & Science Institute (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Sanford Clinical Research

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Swedish Cancer Institute

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98104, United States

  • The Ohio State University, Stefanie Spielman Comprehensive Breast Center

    RECRUITING

    Columbus, Ohio, 43212, United States

  • University Pittsburgh Medical Center

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arizona

    ACTIVE_NOT_RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California - Davis, Comprehensive Cancer Center

    RECRUITING

    Davis, California, 95817, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093-0698, United States

    Contact Email: •••••@•••••

  • University of California San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94115, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60453, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas

    ACTIVE_NOT_RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania (U Penn)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Wilmot Cancer Institute

    RECRUITING

    Rochester, New York, 14642, United States

    Contact Email: •••••@•••••

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Texas, M.D. Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77230-1439, United States

  • University of Texas, Southwestern Medical Center

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75390-9155, United States

  • University of Washington

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98115, United States

  • Vanderbilt University Medical Center

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 27204, United States

  • Wake Forest Baptist Comprehensive Cancer Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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