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.

Anastrozole + Goserelin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Objective Response Rate (ORR)

Clinical Benefit Rate

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Response Rates

Time-to-Progression (TTP)

Overall Survival (OS)

Mean at Baseline

Mean at 1 month treatment

Mean at 3 months treatment

Mean at 6 months treatment

Estradiol Suppression

Serious Adverse Events

Overall Study

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Taxane

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy

Goserelin (Zoladex) plus Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy

AC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos)

Standard cyclophosphamide

Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo

Adher Al Sayed, MD

This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.

Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

King Faisal Specialist Hospital & Research Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Teuvo L Tammela, Professor

To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)

FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Finnish Prostate Cancer Group

Tampere University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women	NCT00186121	Breast Cancer	Anastrozole (Ar... Goserelin (Zola...	18 Years - 70 Years	Stanford University
Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer	NCT01530607	Breast Cancer	Standard cyclop... Goserelin (Zola...	18 Years - 50 Years	King Faisal Specialist Hospital & Research Center
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer	NCT00293670	Patients With T...	Goserelin (Zola...	0 Years -	Tampere University

Spots Global Cancer Trial Database for goserelin (zoladex)