Evidence map›Paper›PMID 25847929›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105.

Melinda L Telli, Kristin C Jensen, Shaveta Vinayak, Allison W Kurian, Jafi A Lipson, Patrick J Flaherty, Kirsten Timms, Victor Abkevich, Elizabeth A Schackmann, Irene L Wapnir and 11 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05901025 (Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients), which is not on this map. Cited by 135 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
135citing papers in PubMed, 4 pooled it
14.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05901025 not yet recruitingnot on this mapstarted 2023, after this paper: background citation

Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients: A Multi-center, Prospective, Observational Study

TypeobservationalSponsorShanghai Jiao Tong University School of MedicineRan2023 to 2033Enrolled5,000ConditionsBreast Cancer
3 · Its place in the literature

Who cites it

135 citing papers in PubMed, 4 syntheses or guidelines pooled it, 226 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. [BRCA-like breast cancer patients benefit from cisplatin plus veliparib-results from the S1416 phase II study].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Trial
  6. Trial
  7. Trial
  8. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in GermlineJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  9. Trial
  10. TumorClinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Therapeutic Potential of Metal-Based and PARP Inhibitor Chemotherapy forInternational journal of molecular sciences · 2025
    Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review

75 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 2 institutions in 1 country.

Melinda L TelliMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA. mtelli@stanford.edu.
Kristin C JensenMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Shaveta VinayakMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Allison W KurianMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Jafi A LipsonMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Patrick J FlahertyMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Kirsten TimmsMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Victor AbkevichMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Elizabeth A SchackmannMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Irene L WapnirMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Robert W CarlsonMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Pei-Jen ChangMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Joseph A SparanoMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Bobbie HeadMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Lori J GoldsteinMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Barbara HaleyMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Shaker R DakhilMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Julia E ReidMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Anne-Renee HartmanMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Judith ManolaMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
James M FordMelinda L. Telli, Kristin C. Jensen, Shaveta Vinayak, Allison W. Kurian, Jafi A. Lipson, Patrick J. Flaherty, Elizabeth A. Schackmann, Irene L. Wapnir, Robert W. Carlson, Pei-Jen Chang, and James M. Ford, Stanford University School of Medicine, Stanford; Bobbie Head, Marin Specialty Care, Greenbrae, CA; Kirsten Timms, Victor Abkevich, Julia E. Reid, and Anne-Renee Hartman, Myriad Genetics, Salt Lake City, UT; Joseph A. Sparano, Albert Einstein College of Medicine, New York, NY; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Barbara Haley, University of Texas Southwestern Medical Center, Dallas, TX; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; and Judith Manola, Dana-Farber Cancer Institute, Boston, MA.
Cancer Center of Kansas · USDana-Farber Cancer Institute · US

Funding

WORD PROCESSORP30CA013330 · NCI · YESHIVA UNIVERSITY · PI THOMAS E ROHAN · 1985 to 2026
$111.2M
Core-010UL1TR001073 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, SHAMOON, HARRY · 2013 to 2017
$21.3M
TRANSLATIONAL RESEARCH ONCOLOGY TRAINING GRANTK12CA076917 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERSON, STANTON L. · 1997 to 2022
$14.2M
Postdoctoral Training in the Radiation ScincesT32CA121940 · NCI · STANFORD UNIVERSITY · PI GRAVES, EDWARD E. · 2007 to 2018
$2.1M
NCATS NIH HHS UL1 TR001073NCI NIH HHS K12 CA076917NCI NIH HHS P30 CA013330NCI NIH HHS T32 CA121940
6 · The paper itself

Abstract

purposeThis study was designed to assess efficacy, safety, and predictors of response to iniparib in combination with gemcitabine and carboplatin in early-stage triple-negative and BRCA1/2 mutation-associated breast cancer. PATIENTS AND

methodsThis single-arm phase II study enrolled patients with stage I to IIIA (T ≥ 1 cm) estrogen receptor-negative (≤ 5%), progesterone receptor-negative (≤ 5%), and human epidermal growth factor receptor 2-negative or BRCA1/2 mutation-associated breast cancer. Neoadjuvant gemcitabine (1,000 mg/m(2) intravenously [IV] on days 1 and 8), carboplatin (area under curve of 2 IV on days 1 and 8), and iniparib (5.6 mg/kg IV on days 1, 4, 8, and 11) were administered every 21 days for four cycles, until the protocol was amended to six cycles. The primary end point was pathologic complete response (no invasive carcinoma in breast or axilla). All patients underwent comprehensive BRCA1/2 genotyping, and homologous recombination deficiency was assessed by loss of heterozygosity (HRD-LOH) in pretreatment core breast biopsies.

resultsAmong 80 patients, median age was 48 years; 19 patients (24%) had germline BRCA1 or BRCA2 mutations; clinical stage was I (13%), IIA (36%), IIB (36%), and IIIA (15%). Overall pathologic complete response rate in the intent-to-treat population (n = 80) was 36% (90% CI, 27 to 46). Mean HRD-LOH scores were higher in responders compared with nonresponders (P = .02) and remained significant when BRCA1/2 germline mutations carriers were excluded (P = .021).

conclusionPreoperative combination of gemcitabine, carboplatin, and iniparib is active in the treatment of early-stage triple-negative and BRCA1/2 mutation-associated breast cancer. The HRD-LOH assay was able to identify patients with sporadic triple-negative breast cancer lacking a BRCA1/2 mutation, but with an elevated HRD-LOH score, who achieved a favorable pathologic response. Confirmatory controlled trials are warranted.

Indexed as

Genomic InstabilityMastectomy, SegmentalAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBRCA1 ProteinBRCA2 ProteinCarboplatinDeoxycytidineDrug Administration ScheduleFemaleGemcitabineGene Expression ProfilingHumansMiddle AgedBenzamidesBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCarboplatinDeoxycytidineGemcitabineiniparib

Identifiers

PMID25847929
PMCPMC4451172
OpenAlexW2105265201

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.