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

Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888082

Acronym

PROOF

Enrollment

102

Registered

2009-04-24

Start date

Unknown

Completion date

2012-04-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Ovarian Function

Keywords

adjuvant chemotherapy, breast cancer, goserelin acetate, ovarian function, Chemotherapy, Primary invasive breast cancer

Brief summary

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.

Interventions

DRUGGoserelin acetate

3.6 mg depot injectable preparation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)	Each 3 months
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles	Each 3 months

Secondary

Measure	Time frame
Quality of life (QOL) through-out the study measured by FACT-ES scale.	Each 3 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026