Can a genetic test pick the best chemo for triple negative breast cancer?
NCT ID NCT01982448
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two chemotherapy drugs, cisplatin and paclitaxel, given before surgery to 147 women with triple negative breast cancer. The goal was to see if a genetic test called HRD could predict which drug would work better. Researchers measured how much the tumor shrank after treatment to compare the drugs and the test's accuracy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin and paclitaxel (chemotherapy drugs)
- What this could lead to
- If successful, this could help doctors choose the best chemotherapy for each patient based on a genetic test, improving treatment outcomes for triple negative breast cancer.
- What could go wrong
- This is a phase II trial with only 147 participants, so results may not apply to all patients. The HRD test may not reliably predict response, and the study is already completed, meaning findings are preliminary.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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147 people
The number who actually took part.
- Start date
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Apr 2014
- Finished
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Aug 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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: 1. Participants must meet the following criteria on screening examination to be eligible to participate in the study 2. Pathologic documentation of invasive breast cancer by biopsy (FNA alone is not adequate). 3. AJCC clinical stage I with T1 \> 1.5 cm, stage II or III invasive breast cancer. 4. Participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study and no tumor is HER2-positive. 5. Tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC) assays and /or lack of gene amplification by FISH defined as a ratio \< 2 on invasive tumor by local review. 6. ER and PgR status by IHC must be known. Tumor must be ER and PR negative (≤5% staining) by local review. 7. Known BRCA1/2 (BReast CAncer) status is not required for study entry. However patients known to have a germline deleterious BRCA1/2 mutation should be encouraged to consider a preoperative trial specifically designed for BRCA1/2 carriers, if available. 8. Breast imaging should include imaging of the ipsilateral axilla. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to confirm the presence of metastatic disease in the lymph nodes. For patients with a clinically negative axilla, baseline assessment of the axilla will be performed at the discretion of the treating investigator. For patients with pathologically positive axillary lymph nodes prior to preoperative therapy, a level I and II lymph node dissection at the time of definitive surgery is recommended. 9. Patients with a prior history of contra-lateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the last 5 years. 10. Women ≥ 18 years of age. 11. ECOG performance status ≤1 (see Appendix A). 12. Laboratory Evaluation 1) Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2) Platelet count ≥ 100,000/ mm3 3) Bilirubin ≤ 1.5x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin 4) ALT, AST ≤3.0 x ULN ALK Phos \<2.5 x ULN 5) Creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min 6) Hemoglobin ≥ 9 mg/dl 7) Use of an effective means of contraception is required in subjects of childbearing potential since study agents are known to be teratogenic. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 8) Ability to understand and the willingness to sign a written informed consent document 9) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy and did not receive prior chemotherapy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. 10) Patient must be willing to undergo mandatory research biopsy and blood draw. Prior to biopsy procedures patients must be able to be off medications that could increase the risk of bleeding Exclusion Criteria: 1. Participants with axillary adenopathy only are not eligible for this study. 2. Prior chemotherapy: Prior non-taxane or platinum containing chemotherapy will be allowed if the prior exposure was at least 5 years ago and the exposure is thought not to potentially interact with the primary outcome of the trial or put the patient at undue risk, and should be reviewed with study PI on a case by case basis. 3. Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy. 4. Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast conserving treatment and hormonal therapy for DCIS or invasive breast cancer. 5. Ongoing use of any other investigational or study agents. 6. Peripheral neuropathy of any etiology \> grade 1 (NCI CTCAE Version 4.0- Appendix B) 7. Significant hearing loss that would prevent cisplatin administration. 8. Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification (i.e., Cre \> 1.5 mg/dl or GFR \< 60 cc/min).
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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
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Duke University
Durham, North Carolina, 27710, United States
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Indiana University- Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center-Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center-Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Cancer Center-Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Cancer Center-Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Cancer Center-Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
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Memorial Sloan Kettering Cancer Center-West Harrison
Harrison, New York, 10604, United States
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Seattle Cancer Alliance at EvergreenHealth
Kirkland, Washington, 98034, United States
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South Shore Hospital
Weymouth, Massachusetts, 02190, United States
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of North Carolina- Lineberger Cancer Center
Chapel Hill, North Carolina, 27599, United States
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University of Washignton
Seattle, Washington, 98195, United States
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Universtiy of Pittsburgh- Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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