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Preoperative Carboplatin–Paclitaxel–Bevacizumab in Triple-Negative Breast Cancer: Final Results of the Phase II Ca.Pa.Be Study

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Purpose

The phase II Ca.Pa.Be trial evaluated preoperative carboplatin–paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II–III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

Methods

Patients with hormone receptor-negative, HER-2-negative stage II–III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day −6). DCE-MRI was repeated before the initiation of chemotherapy.

Results

Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 %) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 %). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 %). Bevacizumab-associated adverse events (AEs) were mild: G1–2 hypertension and bleeding occurred in 6 (13.6 %) and 12 (27 %) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 %), and diarrhea and fatigue (4.5 % each). The only G3–4 hematologic toxicity was neutropenia (G3, 25 %; G4, 9 %). Early assessed DCE-MRI response parameters failed to predict pCR.

Conclusions

The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted.

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Acknowledgment

We thank all the patients who participated in the study. The study was supported by Roche.

Disclosure

The authors declare no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Surgery, Oncology, and Gastroenterology, University of Padova, Padua, Italy

    Valentina Guarneri MD, PhD, Maria Vittoria Dieci MD & PierFranco Conte MD

  2. Division of Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy

    Valentina Guarneri MD, PhD, Maria Vittoria Dieci MD & PierFranco Conte MD

  3. Department of Medical Oncology, Azienda Ospedaliera ASMN, IRCCS, Reggio Emilia, Italy

    Giancarlo Bisagni MD & Corrado Boni MD

  4. Division of Medical Oncology, Ramazzini Hospital, Carpi, Italy

    Katia Cagossi MD

  5. Department of Medical and Biological Sciences, University of Udine, Udine, Italy

    Fabio Puglisi MD

  6. Department of Medical Oncology, University Hospital of Udine, Udine, Italy

    Fabio Puglisi MD

  7. Department of Radiology, Modena University Hospital, Modena, Italy

    Annarita Pecchi MD

  8. Department of Medical and Surgical Sciences for Children and Adults, University of Modena, Modena, Italy

    Federico Piacentini MD

  9. Division of Medical Oncology, Modena University Hospital, Modena, Italy

    Federico Piacentini MD

Authors
  1. Valentina Guarneri MD, PhD
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  2. Maria Vittoria Dieci MD
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  3. Giancarlo Bisagni MD
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  4. Corrado Boni MD
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  5. Katia Cagossi MD
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  6. Fabio Puglisi MD
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  7. Annarita Pecchi MD
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  8. Federico Piacentini MD
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  9. PierFranco Conte MD
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Corresponding author

Correspondence to Valentina Guarneri MD, PhD.

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Guarneri, V., Dieci, M.V., Bisagni, G. et al. Preoperative Carboplatin–Paclitaxel–Bevacizumab in Triple-Negative Breast Cancer: Final Results of the Phase II Ca.Pa.Be Study. Ann Surg Oncol 22, 2881–2887 (2015). https://doi.org/10.1245/s10434-015-4371-0

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  • DOI: https://doi.org/10.1245/s10434-015-4371-0

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