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Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Neoplasms, Neoplasms, Hormone-Dependent

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Trial Information

Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women.
These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women.
Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane
blocks the formation of estrogens from androgenic precursors in the body via the aromatase
enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen
receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase
inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve
complete suppression of estrogen stimulation of breast cancer cells. This study is designed
to determine whether combined hormonal therapy will lengthen the time to disease progression
and the survival time for subjects with advanced breast cancer.

Inclusion Criteria:

- To be eligible to receive continued treatment, subjects must remain eligible to
receive study drug at the time of their last Biomed 777-CLP-29 visit

- To continue on survival follow-up, subjects must be in survival follow-up in study
Biomed 777-CLP-29

- Written informed consent obtained for subjects who continue study drug treatment

Exclusion Criteria:

- Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any

- Subjects for whom the investigator considers study participation is no longer in the
best interest of those subjects.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm

Principal Investigator

Peter Langecker, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Intarcia Therapeutics


United States: Food and Drug Administration

Study ID:

Biomed 777-CLP-32



Start Date:

November 2005

Completion Date:

June 2006

Related Keywords:

  • Breast Neoplasms
  • Neoplasms, Hormone-Dependent
  • Atamestane
  • Breast neoplasms
  • Combined hormonal therapy
  • Complete estrogen blockade
  • Ductal breast carcinoma
  • Estrogen blocker
  • Fareston┬«
  • Femara┬«
  • First line therapy
  • Letrozole
  • Lobular breast carcinoma
  • Locally advanced breast cancer
  • Locally recurrent breast cancer
  • Maximal estrogen inhibition
  • Metastatic breast cancer
  • Neoplasms, Hormone-dependent
  • Receptor-positive
  • Stage IIIA breast cancer
  • Stage IIIB breast cancer
  • Stage IV breast cancer
  • Toremifene
  • Breast Neoplasms
  • Neoplasms
  • Neoplasms, Hormone-Dependent



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