Clinical trial NCT00186121: Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Official title: A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.

Detailed description: Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin. Participants continued on treatment until disease progression or unacceptable toxicity.

Eligibility criteria: INCLUSION CRITERIA

* Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
* Premenopausal, defined as any of:

  1. Last menstrual period within 3 months, or
  2. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
  3. If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range
* Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Granulocytes \> 1500/mm\^3
* Platelets \> 100,000/mm\^3
* Serum glutamic oxaloacetic transaminase (SGOT) \< 2.5 x upper limit of normal
* Total bilirubin \< 1.5 mg/dL
* May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.
* Must be using effective contraception or not be of childbearing potential
* Signed written informed consent

INCLUSION CRITERIA

* Active, unresolved infection
* Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years
* Prior treatment with an aromatase inhibitor or inactivator
* Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist
* Adjuvant chemotherapy within 6 months of study entry.
* Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment
* Central nervous system metastasis
* Lymphangitic pulmonary metastasis
* Pregnant or lactating

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 months
Secondary outcomes:
measure: Clinical Benefit Rate
timeFrame: 6 months
measure: Response Rates
timeFrame: 6 months
measure: Time-to-Progression (TTP)
timeFrame: up to 63 months
measure: Overall Survival (OS)
timeFrame: up to 63 months
measure: Estradiol Suppression
timeFrame: 6 months
measure: Serious Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Melinda Telli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson RW, Theriault R, Schurman CM, Rivera E, Chung CT, Phan SC, Arun B, Dice K, Chiv VY, Green M, Valero V. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol. 2010 Sep 1;28(25):3917-21. doi: 10.1200/JCO.2009.24.9565. Epub 2010 Aug 2.