Skip to main content Skip to footer
American Family Children's Hospital
SHARE TEXT
 


Print Friendly Page

Protocol No. A011106

Principal Investigator Burkard, Mark

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study

Objective The purpose of the research study is to find out if a drug called fulvestrant or the combination of fulvestrant and another drug called anastrozole, is better than anastrozole alone when given before surgery to shrink your cancer and stop it from growing. These are called endocrine therapies.

Treatment The use of fulvestrant in this study is experimental. Fulvestrant is approved by the US Food and Drug Administration (FDA) for the treatment of patients who have metastatic breast cancer and who have progressed on other endocrine therapy. Fulvestrant is not approved by the FDA for the treatment of patients with non-metastatic breast cancer. This means that it can only be given to patients with non-metastatic disease if they are in a research study. Anastozole has been approved by the FDA for the treatment of non-metastatic breast cancer.

Description You will be "randomized" into one of the three treatment groups (also called treatment "Arms"), described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group that you will be in.

If you are on treatment Arm I: You will take 1 anastrozole tablet once each day for 22-24 weeks (6 cycles). A treatment cycle is defined as 4 weeks.

If you are on treatment Arm II: You will receive two injections of fulvestrant into the muscle of your buttocks (one injection in each buttock) on Days 1 and 15 of the first treatment cycle, and then on Day 1 of every cycle after that for a total 22-24 weeks (6 cycles). A treatment cycle is defined as 4 weeks.

If you are on treatment Arm III: You will take 1 anastrozole tablet once each day for 22-24 weeks (6 cycles). You will also receive two injections of fulvestrant into the muscle of your buttocks (one injection into each buttock) on Days 1 and 15 of the first treatment cycle, and on Day 1 of every cycle after that for a total 22-24 weeks (6 cycles). A treatment cycle is defined as 4 weeks. Click here for more info

Key Eligibility
  • Females 18 years or older who are postmenopausal
  • Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
  • Must be estrogen receptor (ER) positive
  • Must be HER2 negative
  • Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry is not allowed
  • Not eligible if you have prior history of invasive breast cancer or contralateral DCIS

Applicable Disease Sites Breast

Therapies Involved Cytotoxic Chemotherapy; Hormone Therapy; Surgery

Drugs Involved Faslodex (fulvestrant); anastrozole; arimidex (anastrozole); fulvestrant; paclitaxel; taxol (paclitaxel)

Status Open

Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Mercy Health Systems, Janesville ; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park