Researchers are testing whether a combination of the chemotherapy medicine paclitaxel (Taxol) and two anti-HER2 therapies, trastuzumab (Herceptin) and pertuzumab (Perjeta), are safe and effective in treating HER2 positive metastatic breast cancer.
Paclitaxel and trastuzumab are standard treatments for many types of breast cancer. Pertuzumab gained FDA approval for use in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer in summer 2012.
Background and Reason for the Study
In 2009, the CLEOPATRA trial tested the effectiveness of pertuzumab, trastuzumab and docetaxel (Taxotere), another common chemotherapy medicine, in treating metastatic, HER2 positive breast cancer. When pertuzumab started to show promise as an anti-HER2 therapy, researchers at Memorial Sloan-Kettering Cancer Center decided to design a study that would test pertuzumab in combination with trastuzumab and paclitaxel, an alternate taxane to docetaxel.
The study set out to determine if combining pertuzumab with the two other standard treatments was safe, effective and practical.
Participants in this phase II study will receive a combination of the three medicines until the cancer progresses. The regimen includes paclitaxel given weekly by vein, trastuzumab given every three weeks by vein, and pertuzumab given every three weeks by vein. In some cases, participants may receive trastuzumab weekly instead of every three weeks, at the discretion of the trial doctors.
This is an open label study, which means both the participants and doctors know which treatment is being used, unlike in randomized studies, in which participants are assigned treatments by chance.
For the purposes of this study, investigators consider participants who are progression-free after six months of treatment a sign of the treatment’s success. The goal is to determine what proportion of participants benefit from the treatment or experience disease progression at the six-month mark.
Secondary goals include whether tumors shrink or grow, strength of side effects and safety.
Who Is Eligible to Participate?
You may be able to take part in this clinical trial if:
- You are a woman 18 years or older
- You have stage IV HER2 positive breast cancer
- You have had one or no prior treatments for metastatic disease
- You have not been treated with pertuzumab in the past
- Your heart is in good condition
- Your white blood cell, neutrophil and platelet counts are in a normal range
- If you have brain metastasis, brain lesions you have had for two or more months must be stable and treated
Study Locations and Contact Information
This study is being held at five Memorial Sloan-Kettering Cancer Centers: four locations in New York and one in Basking Ridge, New Jersey.
Complete addresses canbe found at ClincalTrials.gov, under identifier NCT01276041. You may also contact Chau Dang, MD (New York locations) at (646) 888-5426 or Sarat Chandarlapaty, MD (Basking Ridge, New Jersey) at (646) 888-5449.
NCT01276041 on ClinicalTrials.gov