Dr. Blackwell on the Impact of the CLEOPATRA and MARIANNE Studies in HER2+ Breast Cancer

Kimberly L. Blackwell, MD
Published: Tuesday, Nov 01, 2016



Kimberly L. Blackwell, MD, medical oncologist, Duke Cancer Institute, discusses the lasting impact that the CLEOPATRA and MARIANNE studies have had on the treatment landscape in HER2-positive breast cancer.

CLEOPATRA was a phase III evaluation of pertuzumab (Perjeta) and trastuzumab (Herceptin) for patients with HER2-positive metastatic breast cancer. This study was important, says Blackwell, because the addition of pertuzumab to trastuzumab demonstrated a significant improvement in overall survival (OS).

MARIANNE compared the taxane/trastuzumab regimen with T-DM1 (ado-trastuzumab emtansine; Kadcyla) or T-DM1 plus pertuzumab, and showed that T-DM1 plus pertuzumab was not a significantly better treatment than T-DM1 alone. Moreover, says Blackwell, T-DM1 alone has demonstrated similar efficacy results to taxane/trastuzumab in terms of progression-free survival.

Despite those findings, Blackwell does not think that the MARIANNE study takes anything away from the CLEOPATRA results, as the addition of pertuzumab to the taxane/trastuzumab regimen significantly improves survival for these patients.

T-DM1 is still being investigated in ongoing trials. Results from the recent phase III TH3RESA trial showed that T-DM1 yielded an increased median OS compared with patients who received treatment of physician’s choice. Also, a phase II clinical trial at Dana-Farber Cancer Institute is currently looking to see if T-DM1 will yield less adverse events than a treatment regimen containing trastuzumab and paclitaxel (Abraxane). The investigators in this study hope to learn more about the long-term benefits and disease-free survival of patients treated with T-DM1, in comparison with patients who receive a combination of trastuzumab and paclitaxel.


Kimberly L. Blackwell, MD, medical oncologist, Duke Cancer Institute, discusses the lasting impact that the CLEOPATRA and MARIANNE studies have had on the treatment landscape in HER2-positive breast cancer.

CLEOPATRA was a phase III evaluation of pertuzumab (Perjeta) and trastuzumab (Herceptin) for patients with HER2-positive metastatic breast cancer. This study was important, says Blackwell, because the addition of pertuzumab to trastuzumab demonstrated a significant improvement in overall survival (OS).

MARIANNE compared the taxane/trastuzumab regimen with T-DM1 (ado-trastuzumab emtansine; Kadcyla) or T-DM1 plus pertuzumab, and showed that T-DM1 plus pertuzumab was not a significantly better treatment than T-DM1 alone. Moreover, says Blackwell, T-DM1 alone has demonstrated similar efficacy results to taxane/trastuzumab in terms of progression-free survival.

Despite those findings, Blackwell does not think that the MARIANNE study takes anything away from the CLEOPATRA results, as the addition of pertuzumab to the taxane/trastuzumab regimen significantly improves survival for these patients.

T-DM1 is still being investigated in ongoing trials. Results from the recent phase III TH3RESA trial showed that T-DM1 yielded an increased median OS compared with patients who received treatment of physician’s choice. Also, a phase II clinical trial at Dana-Farber Cancer Institute is currently looking to see if T-DM1 will yield less adverse events than a treatment regimen containing trastuzumab and paclitaxel (Abraxane). The investigators in this study hope to learn more about the long-term benefits and disease-free survival of patients treated with T-DM1, in comparison with patients who receive a combination of trastuzumab and paclitaxel.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 16th Annual International Congress on the Future of Breast Cancer®Sep 29, 20182.0
School of Breast Oncology®: Mid-Year Video Update OnlineSep 30, 20182.0
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