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Breast Cancer

Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Purpose

The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage HER2-low breast cancer, will prevent breast cancer from returning.

Trastuzumab is called a targeted therapy because it targets the tumor cells by blocking the HER2 protein on the surface of the cancer cell to slow down or stop cancer growth.  Trastuzumab is a standard treatment for HER2-positive breast cancer.  In this study, Trastuzumab is considered to be investigational because it has not been studied for use in treating HER2-low breast cancer.

A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.

Another goal of this study is to find out how the drugs used in this study affect menstrual cycles and if these changes in menstrual cycles have any effect on breast cancer. 

This study is also exploring the possibility that other medical conditions, medications, alcohol intake, smoking and weight may affect breast cancer.

Eligibility

Eligibility criteria include the following:

  • Must have a unilateral invasive adenocarcinoma of the breast
  • Estrogen and Progesterone analysis must be performed on the primary tumor
  • The primary tumor must be evaluated and must indicate that the tumor is HER2-low
  • May have had either breast-conserving surgery or a total mastectomy
  • Sentinel or axillary lymph nodes must have been evaluated
  • Registration/Randomization must take place within 84 days of surgery
  • Must not have T4 tumors including inflammatory breast cancer
  • Must not have radiological evidence of metastatic disease
  • Must not have previous history of breast cancer
  • Must not have previous chemotherapy or trastuzumab for any malignancy
  • Must not have started chemotherapy or trastuzumab for their diagnosed breast cancer prior to registration into the study
  • Must be female
  • Must be at least 18 years of age
  • Must not have a history of or active cardiac disease
  • Must not have uncontrolled hypertension
  • Must not have active hepatitis B or hepatitis C
  • Must not have intrinsic lung disease with shortness of breath
  • Must not have poorly controlled diabetes
  • Must not have an active or chronic infection requiring chronic antibiotics
  • Must not have a nervous system disorder (parethesias or neuropathies)
  • Must not have chronic daily treatment with corticosteroids
  • Must not be pregnant or nursing
  • Must not have any psychiatric or addictive disorders or other conditions that would preclude patients from meeting study requirements
  • Must not have used any investigational products within the last 30days prior to registration in the study

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment

Patients will be assigned to one of four groups:

ARM 1A:

  • Docetaxel + cyclophosphamide chemotherapy

ARM 1B:

  • Doxorubicin + cyclophosphamide chemotherapy followed by weekly paclitaxel chemotherapy

ARM 2A:

  • Docetaxel + cyclophosphamide chemotherapy + trastuzumab

ARM 2B:

  • Doxorubicin + cyclophosphamide chemotherapy followed by weekly paclitaxel chemotherapy + trastuzumab

Physical exams and blood tests will be required during treatment.  Echocardiograms to check for changes in heart function that could be caused by doxorubicin or trastuzumab will also be required. 

Visits will be required every six months until five years after joining the study and yearly until ten years after joining the study.