Clinical Trials Detail

ALLIANCE A011106 - ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study

Objective

Diseases

Clinical Stage II or III estrogen receptor positive breast cancer in postmenopausal women

Description

This clinical trial is evaluating a different way of treating larger estrogen receptor positive breast cancers (>2 cm) in postmenopausal women. These patients will start medications to try to shrink the tumor before surgery. They will be randomly assigned to three groups, daily anastrozole pill, monthly fulvesterant injection or both. Anastrozole works by lowering the amount of estrogen produced by the body. Fulvesterant works by blocking the ability of estrogen to stimulate the cancer by attaching to the cancer's estrogen receptors. A biopsy of the tumor is required at the start of the trial. After 4 weeks on the medication, a repeat biopsy will be performed to assess response to treatment. If there has not been a good response, patients will move on to chemotherapy or surgery. Those with a good response will stay on the medications for up to 6 months, then proceeding with surgery. The tumor will be biopsied again at the time of surgery, and if continued good response, chemotherapy will not be recommended. Patients and their surgeon will maintain shared decision making about the type of surgery (breast conservation or mastectomy). Some patients who are not initially candidates for breast conservation will become candidates after taking the medications on this trial.

Objectives

  • To see whether a drug called fulvestrant works better than a drug called anastrozole in decreasing the proportion of endocrine resistant tumors. Both drugs will also be given together to see if the combination works better than each drug along.
  • To see if a prognostic indicator can predict how well patients will do.

Participating Physician Clinics

Boston Baskin Cancer Foundation-Memphis

Clinical Trial Categories

  • Breast Cancer
Sponsor(s)
Alliance for Clinical Trials in Oncology
How to Participate

Partial inclusion criteria

Patient is postmenopausal with pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy ER+ Her2-

For the current eligibility status of this clinical study, referring physicians may call the Baptist referral line at 901-227-DOCS (3627).