Alliance A011106

Trial

Clinical Trial Title

Alliance A011106

Trial Status

Open to Enrollment

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Eligibility Criteria

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

  •  Female ≥ 18 years of age
  •  ECOG performance status 0-2
  •  Postmenopausal, verified by:
  • Post bilateral surgical oophorectomy, or
  • No spontaneous menses > 1 year or
  • No menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
  • Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
  • The extent of disease is a solitary lesion where the lesion is:
  •  palpable
  •  its size can be measured bidimensional by tape, ruler or caliper technique, and
  •  its largest tumor diameter is at least 2.0 cm (that is considered measurable by the WHO criteria)
Note:
• Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible.

Treatment:

If you are randomized to treatment Group I (anastrozole): You will take 1 anastrozole tablet once each day for 22 - 24 weeks (6 cycles). A treatment cycle is defined as 4 weeks. The last tablet will be taken the day before your surgery. Take the anastrozole by mouth, with a large glass of water (8 ounces) with or without food. If you miss a dose of anastrozole, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your regularly scheduled dose. Do not take two doses in the same day.

If you are randomized to treatment Group II (fulvestrant): 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 4-week cycle after that, for a total 22 - 24 weeks (6 cycles).

If you are randomized to treatment Group III (anastrozole + fulvestrant): You will take 1 anastrozole tablet once each day for 22 - 24 weeks (6 cycles). The last tablet will be taken the day before your surgery. Take the anastrozole by mouth, with a large glass of water (8 ounces) with or without food. 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 4-week cycle after that, for a total 22-24 weeks (6 cycles). If you miss a dose of anastrozole, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your regularly scheduled dose. Do not take two doses in the same day.

IRB Number

Legacy IRB

Notes

Sponsored by Alliance for Clinical Trials

Principal Investigator Name

Regan Look, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Last Updated: Monday, August 25, 2014 04:34:32 PM