Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00186121
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anastrozole + Goserelin Goserelin (Zoladex) Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole. Anastrozole + Goserelin Anastrozole (Arimidex) Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 3 months ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.
* CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.
* PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.
All measurements by ruler or calipers.
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate 6 months The overall clinical benefit rate of goserelin followed by anastrozole was evaluated, as determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate.
* CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.
* PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.
* SD = No significant change in measurable or evaluable disease for at least 4 weeks.
All measurements by ruler or calipers.Overall Survival (OS) up to 63 months Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.
Estradiol Suppression 6 months Plasma estradiol determinations were performed at baseline, 1 month, 3 months, and 6 months using the Coat-A-Count Estradiol competitive binding assay system, which has a calibrated range for estradiol of 20 to 3,600 pg/mL with an analytical sensitivity of 10 pg/mL.
Serious Adverse Events 6 months The toxicity of the treatment regimen of goserelin followed by anastrozole is estimated by the rate of Serious Adverse Events (SAEs) that occurred during the course of the study.
Response Rates 6 months The numbers of participants with metastatic breast cancer experiencing Complete Response (CR); Partial Response (PR); or Stable Disease (SD) after treatment with goserelin followed by anastrozole are reported.
* CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.
* PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.
* SD = No significant change in measurable or evaluable disease for at least 4 weeks.
All measurements by ruler or calipers.Time-to-Progression (TTP) up to 63 months Time-to-progression (TTP) was assessed as the median observed in the participant group.
Progression of disease was considered, per protocol, to be ≤ 25% increase in the area of any malignant lesion greater than 2 square cm, or ≤ 25% increase in the sum of the products of the longest perpendicular diameters of individual lesions in a given organ, when compared to baseline values or after therapeutic response.
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States