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Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Histologically confirmed breast cancer meeting 1 of the following criteria:

- Metastatic disease (M1)

- Multiple sites of new disease that is clinically obvious metastatic disease
(e.g., multiple sites of new osseous disease)

- Measurable or nonmeasurable disease

- No known brain or CNS metastases

- Hormone receptor status:

- Estrogen-receptor positive* AND/OR

- Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of
> 10 fmol/mg cytosol protein by ligand binding assay or positive by



- Not specified


- Female

Menopausal status

- Postmenopausal, as defined by 1 of the following:

- Prior bilateral oophorectomy

- More than 12 months since last menstrual period with no prior hysterectomy

- At least 55 years of age with prior hysterectomy

- Under 55 years of age with a prior hysterectomy without oophorectomy and with
estradiol and follicle-stimulating hormone levels consistent with menopause

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting
factor deficiency)


- INR ≤ 1.6


- Not specified


- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission


Biologic therapy

- No prior immunotherapy for recurrent or metastatic disease


- No prior chemotherapy for recurrent or metastatic disease

- More than 12 months since prior adjuvant or neoadjuvant chemotherapy

- No concurrent chemotherapy for malignancy

Endocrine therapy

- Prior adjuvant hormonal therapy allowed

- At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH)

- Menstrual periods must not have resumed since LHRH therapy

- More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g.,
anastrozole, letrozole, or exemestane)

- More than 12 months since prior fulvestrant

- No prior hormonal therapy for recurrent or metastatic disease

- No other concurrent hormonal therapy for malignancy

- No concurrent hormone replacement therapy


- Not specified


- Not specified


- No long-term anticoagulant therapy (except antiplatelet therapy)

Gender: Female
Steward Physician(s)
  • Rita S. Mehta, MD
  • Theodore A. Vandenberg, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
  • anastrozole
  • fulvestrant
Physician Researcher

Investigator Name:

  • Rita S. Mehta, MD
  • Theodore A. Vandenberg, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00075764
Volunteers:  Not Accepting Healthy Volunteers

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