Evidence map›Paper›PMID 35044810›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer.

Jonathan H Shepherd, Karla Ballman, Mei-Yin C Polley, Jordan D Campbell, Cheng Fan, Sara Selitsky, Aranzazu Fernandez-Martinez, Joel S Parker, Katherine A Hoadley, Zhiyuan Hu and 21 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00861705 (Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer), which is not on this map. Cited by 108 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00861705 phase2completednot on this map

Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2009 to 2025Enrolled454ConditionsMale Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7ArmsBevacizumab, Carboplatin, Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  5. Platinum-based chemotherapy for early triple-negative breast cancer.The Cochrane database of systematic reviews · 2023
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48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Jonathan H ShepherdLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0001-6322-6347
Karla BallmanAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
Mei-Yin C PolleyDepartment of Public Health Sciences, University of Chicago, Chicago, IL.ORCID 0000-0003-0106-0323
Jordan D CampbellAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
Cheng FanLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Sara SelitskyQuantBio LLC, Durham, NC.
Aranzazu Fernandez-MartinezLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0002-2311-4356
Joel S ParkerLife Edit Therapeutics, RTP, NC.
Katherine A HoadleyLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0002-1216-477X
Zhiyuan HuLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0002-2963-2453
Yan LiLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Matthew G SolowayLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Patricia A SpearsLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Baljit SinghWhite Plains Hospital, White Plains, NY.
Sara M TolaneyDana-Farber/Partners CancerCare, Boston, MA.ORCID 0000-0002-5940-8671
George SomloCity of Hope Comprehensive Cancer Center, Duarte, CA.
Elisa R PortMount Sinai Medical Center, New York, NY.ORCID 0000-0003-2130-732X
Cynthia MaWashington University School of Medicine, St Louis, MO.ORCID 0000-0002-8156-7492
Charles KuzmaFirstHealth Sanford Hematology and Oncology, Sanford, NC.
Eleftherios MamounasUF Health Cancer Center Orlando, Orlando, FL.
Mehra GolshanYale Cancer Center, Yale School of Medicine, New Haven, CT.
Jennifer R BellonDana-Farber/Partners CancerCare, Boston, MA.ORCID 0000-0001-6241-0230
Deborah CollyarPatient Advocates In Research, Danville, CA.ORCID 0000-0003-0886-0964
Olwen M HahnUniversity of Chicago Medical Center, Chicago, IL.
Clifford A HudisMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0001-7144-8791
Eric P WinerDana-Farber/Partners CancerCare, Boston, MA.ORCID 0000-0002-8819-1723
Ann PartridgeDana-Farber/Partners CancerCare, Boston, MA.ORCID 0000-0002-4722-4824
Terry HyslopDepartment of Biostatistics & Bioinformatics, School of Medicine, Duke University, Durham, NC.
Lisa A CareyDivision of Hematology-Oncology, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0003-2388-4649
Charles M PerouLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0001-9827-2247
William M SikovProgram in Women's Oncology, Women and Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, RI.ORCID 0000-0001-5451-6449

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI JOHN N. NORTON · 1985 to 2026
$174.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CHARLES M PEROU · 1992 to 2026
$59.3M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
THE ALLIANCE NCTN BIOREPOSITORY AND BIOSPECIMEN RESOURCEU24CA196171 · NCI · WASHINGTON UNIVERSITY · PI Mine Cicek, Wendy Frankel · 2015 to 2026
$35.0M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014236NCI NIH HHS P30 CA033572NCI NIH HHS P50 CA058223NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196171NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233253NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233327NCI NIH HHS UG1 CA233333NCI NIH HHS UG1 CA233339NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

purposeCALGB 40603 (NCT00861705), a 2 × 2 randomized phase II trial, demonstrated that adding carboplatin or bevacizumab to weekly paclitaxel (wP) followed by doxorubicin and cyclophosphamide significantly increased the pathologic complete response (pCR) rate in stage II-III triple-negative breast cancer. We now report long-term outcomes (LTOs) and correlative science end points. PATIENTS AND

methodsThe Kaplan-Meier method was used to estimate LTOs in 443 patients who initiated study treatment. Log-rank tests and Cox proportional hazards models evaluated the impact of clinical characteristics, pathologic response, calculated residual cancer burden (RCB) in patients with residual disease (RD), treatment assignment, and dose delivery during wP on LTOs, including event-free survival (EFS). Genomic predictors of treatment response and outcomes were assessed on pretreatment tumor samples by mRNA sequencing.

resultsAmong baseline characteristics, only the clinical stage was associated with LTOs. At a median follow-up of 7.9 years, LTOs were not significantly improved with either carboplatin or bevacizumab, overall or in patients with basal-like subtype cancers by genomic analysis. Patients with pCR (n = 205, 46.3%) had significantly higher 5-year EFS (85.5%

conclusionDespite higher pCR rates, neither carboplatin nor bevacizumab appeared to improve LTOs although the study was not powered to assess these secondary end points. pCR was associated with superior LTOs even when compared with minimal RD. Markers of immune activation in pretreatment tumor biopsies were independently associated with higher pCR rates and improved survival.

Indexed as

Breast NeoplasmsTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinFemaleHumansNeoadjuvant TherapyNeoplasm, ResidualPaclitaxelBevacizumabCarboplatinPaclitaxel

Identifiers

PMID35044810
PMCPMC9015203

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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.