Triple Negative Breast CancerPhase 2NCT01982448
Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
A Phase 2 study testing Cisplatin and Paclitaxel in people with Triple Negative Breast Cancer, run by Dana-Farber Cancer Institute at 20 sites in United States.
Trial summary
This is a phase II study randomizing patients with stage I with T1 > 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Cisplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 20 sitesUnited States
- Study dates
- Apr 2014to Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Memorial Sloan Kettering Cancer Center-Basking Ridge
Basking Ridge, New Jersey, 07920
University of Alabama
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina- Lineberger Cancer Center
Chapel Hill, North Carolina, 27599
Memorial Sloan Kettering Cancer Center-Commack
Commack, New York, 11725
Duke University
Durham, North Carolina, 27710
Memorial Sloan Kettering Cancer Center-West Harrison
Harrison, New York, 10604
Baylor College of Medicine
Houston, Texas, 77030
Indiana University- Simon Cancer Center
Indianapolis, Indiana, 46202
Seattle Cancer Alliance at EvergreenHealth
Kirkland, Washington, 98034
Memorial Sloan Kettering Cancer Center-Monmouth
Middletown, New Jersey, 07748
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Universtiy of Pittsburgh- Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Memorial Sloan Kettering Cancer Center-Rockville Centre
Rockville Centre, New York, 11570
University of Washignton
Seattle, Washington, 98195
Memorial Sloan Kettering Cancer Center-Sleepy Hollow
Sleepy Hollow, New York, 10591
South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker
This is a phase II study randomizing patients with stage I with T1 > 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to preoperative chemotherapy.
Read the detailed description
Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination deficiency (HRD) assay (Myriad Genetics, Inc.) detects impaired double-strand DNA break repair and may identify patients with BRCA1/2-proficient tumors that are sensitive to DNA-targeting therapy. The primary objective of TBCRC 030 was to detect an association of HRD with pathologic response (residual cancer burden (RCB)-0/1) to singleagent cisplatin or paclitaxel. This prospective phase II study enrolled patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC in a 12-week randomized study of preoperative cisplatin or paclitaxel. The HRD assay was carried out on baseline tissue; positive HRD was defined as a score >=33. Crossover to an alternative chemotherapy was offered if there was inadequate response.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Cisplatin, Paclitaxel
- Keywords
- TRIPLE NEGATIVE BREAST CANCER, CISPLATIN, PACLITAXEL
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol ®-AQ
PaclitaxelDrug
Also called Taxol
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Cisplatin | Experimental | Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. Receives: Drug: Cisplatin |
| Arm B: Paclitaxel | Experimental | Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.
Measured: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Secondary outcomes (4)
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). pCR is defined as RCB-0. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.
Measured: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number of Pathologic Response
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.
Measured: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number With Pathologic Response
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.
Measured: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Positive Predictive Value (PPV) of HRD Score
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33. PPV was calculated as the probability of pathological response among the HRD positive group.
Measured: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionJan 2019
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Myriad Genetics, Inc., Translational Breast Cancer Research Consortium
- Responsible party
- Principal investigator, Erica Mayer, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Erica Mayer, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982448
- Sponsor's protocol ID
- 13-383
- Other IDs
- TBCRC030
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2013
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Ann Oncol. 2020 Nov;31(11):1518-1525. doi: 10.1016/j.annonc.2020.08.2064. Epub 2020 Aug 13.
PubMed 32798689Nader-Marta G, Chu X, Mukhopadhyay S, Abramson VG, Brufsky A, Stringer-Reasor EM, Dent SF, Traina TA, Carey LA, Rimawi MF, Specht JM, Miller KD, Santa-Maria CA, Dasgupta T, Kurt BB, DeMeo M, Krop IE, Tung NM, Schnitt SJ, Tayob N, Mayer EL. Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030). J Natl Cancer Inst. 2026 Jan 1;118(1):141-149. doi: 10.1093/jnci/djaf289.
PubMed 41075163
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker
- ClinicalTrials.gov ID
- NCT01982448
- Acronym / sponsor ID
- 13-383
- Conditions
- Triple Negative Breast Cancer
- Keywords
- TRIPLE NEGATIVE BREAST CANCER, CISPLATIN, PACLITAXEL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Myriad Genetics, Inc., Translational Breast Cancer Research Consortium
- Study start
- Apr 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study randomizing patients with stage I with T1 > 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to preoperative chemotherapy.
Detailed description
Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination deficiency (HRD) assay (Myriad Genetics, Inc.) detects impaired double-strand DNA break repair and may identify patients with BRCA1/2-proficient tumors that are sensitive to DNA-targeting therapy. The primary objective of TBCRC 030 was to detect an association of HRD with pathologic response (residual cancer burden (RCB)-0/1) to singleagent cisplatin or paclitaxel. This prospective phase II study enrolled patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC in a 12-week randomized study of preoperative cisplatin or paclitaxel. The HRD assay was carried out on baseline tissue; positive HRD was defined as a score >=33. Crossover to an alternative chemotherapy was offered if there was inadequate response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Cisplatin | Experimental | Drug: CisplatinCisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. |
| Arm B: Paclitaxel | Experimental | Drug: PaclitaxelPaclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: Platinol ®-AQ | Drug | Arm A: Cisplatin |
| PaclitaxelAlso: Taxol | Drug | Arm B: Paclitaxel |
Primary outcome
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
Time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.
4 secondary outcomes
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status
Time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number of Pathologic Response
Time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number With Pathologic Response
Time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Positive Predictive Value (PPV) of HRD Score
Time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32798689Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Ann Oncol. 2020 Nov;31(11):1518-1525. doi: 10.1016/j.annonc.2020.08.2064. Epub 2020 Aug 13.
- Derived from this study: PubMed 41075163Nader-Marta G, Chu X, Mukhopadhyay S, Abramson VG, Brufsky A, Stringer-Reasor EM, Dent SF, Traina TA, Carey LA, Rimawi MF, Specht JM, Miller KD, Santa-Maria CA, Dasgupta T, Kurt BB, DeMeo M, Krop IE, Tung NM, Schnitt SJ, Tayob N, Mayer EL. Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030). J Natl Cancer Inst. 2026 Jan 1;118(1):141-149. doi: 10.1093/jnci/djaf289.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Mayer, MD principal investigator
Dana-Farber Cancer Institute
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Paclitaxel in people with Triple Negative Breast Cancer, run by Dana-Farber Cancer Institute at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status (time frame: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.