Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Reproductive Control Agents

Antineoplastic Agents

Hormones

Epinephrine

Estrogens

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Goserelin

Anastrozole

Aromatase Inhibitors

Racepinephrine

Epinephryl borate

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

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 is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone

Anastrozole (Arimidex)

Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women

Goserelin (Zoladex)

Melinda Telli, MD

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.

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.

Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

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.

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.

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) 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.

Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.

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.

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.

AstraZeneca

Stanford University

Assistant Professor

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.

Spots Global Cancer Trial Database for Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

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