# CALGB 40603 (Alliance)

Source: https://onco.cc/trials/calgb-40603/  
OnCo record `calgb-40603` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CALGB 40603 showed that adding carboplatin to pre-operative chemotherapy made more triple-negative tumours disappear, but at nearly eight years of follow-up neither carboplatin nor bevacizumab clearly improved survival, in a trial too small to prove that either way.

## Summary

CALGB 40603 (NCT00861705) was a randomised 2 by 2 factorial phase 2 trial in 454 registered patients (443 treated) with stage II to III triple-negative breast cancer, testing the addition of carboplatin and of bevacizumab to weekly paclitaxel followed by dose-dense doxorubicin and cyclophosphamide before surgery. Both additions raised the pathological complete response rate in the primary report (JCO 2015). At a median follow-up of 7.9 years (JCO 2022) long-term outcomes were not significantly improved by either drug, overall or in basal-like tumours defined by gene expression, in a trial not powered for those secondary endpoints. Pathological complete response (46.3 percent of patients) carried a five-year event-free survival of 85.5 percent against 56.6 percent without it, and was superior even to minimal residual disease; markers of immune activation in the pretreatment biopsy independently predicted response and survival.

With GeparSixto (disease-free survival gain) and BrighTNess (event-free survival gain) this is the third trial of the platinum debate: the pathological complete response gain is consistent across all three, the survival gain is seen in the two European trials and not in this one, and carboplatin became the platinum of the KEYNOTE-522 backbone on that combined reading.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Also known as: CALGB 40603; Alliance 40603
- Registry id: NCT00861705
- Phase: 2
- Setting: Stage II to III triple-negative breast cancer: neoadjuvant weekly paclitaxel with or without carboplatin and with or without bevacizumab (2 by 2 factorial), followed by dose-dense doxorubicin and cyclophosphamide, United States
- Sponsor: National Cancer Institute (NCI) / Alliance
- Enrolled: 454
- Result: Carboplatin and bevacizumab each raised pCR; at 7.9 years neither improved event-free or overall survival (not powered). pCR: 5-year EFS 85.5% vs 56.6%.
- Outcomes: Event-free survival at 5 years by pathological response: Pathological complete response 85.5% vs Residual disease 56.6%
- Replication: GeparSixto and BrighTNess found the same pCR gain from carboplatin and, unlike this trial, a disease-free or event-free survival gain.

## Sources

- ClinicalTrials.gov NCT00861705: https://clinicaltrials.gov/study/NCT00861705
- Sikov et al., JCO 2015: primary pCR results: https://doi.org/10.1200/JCO.2014.57.0572
- Shepherd et al., JCO 2022: long-term outcomes and genomic correlates: https://doi.org/10.1200/JCO.21.01506

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- institutions: [Alliance for Clinical Trials in Oncology](https://onco.cc/institutions/alliance-oncology/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/)
- trials: [BrighTNess](https://onco.cc/trials/brightness/), [GeparSixto](https://onco.cc/trials/geparsixto/), [KEYNOTE-522](https://onco.cc/trials/keynote-522/)

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