Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy (PROOF)

AstraZeneca

Status and phase: Withdrawn; Phase 3

Conditions: Breast Cancer; Ovarian Function

Treatments: Drug: Goserelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888082

D8664L00012

Details and patient eligibility

About

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements.

The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed invasive breast carcinoma
• Candidates for adjuvant chemotherapy for primary breast cancer
• Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels

Exclusion criteria

• Previous systemic chemotherapy
• Pregnancy
• Stage IV breast cancer

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

A

No Intervention group

Description:

Patients receiving only adjuvant chemotherapy

B

Experimental group

Description:

Patient receiving goserelin acetate along with adjuvant chemotherapy

Treatment:

Drug: Goserelin acetate