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Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]

Phase 3
Open (Enrolling)
Breast Cancer, Infertility, Menopausal Symptoms

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Trial Information

Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]



- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal
women with stage I-III breast cancer treated with goserelin vs no goserelin .


- Compare the quality of life of patients treated with these regimens.

- Compare menopausal symptoms in patients treated with these regimens.

- Compare bone mineral density loss in patients treated with these regimens.

- Compare hormone levels in patients treated with these regimens.

- Compare menstruation in patients treated with these regimens.

- Compare the incidence of pregnancy in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study.
Patients are stratified according to age (≤ 40 years vs > 40 years) and participating
center. Patients are randomized to 1 of 2 treatment arms.

Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide-
and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the
absence of disease progression or unacceptable toxicity.

Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive
neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin
subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy.
Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.

Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually
for up to 5 years.

After completion of study therapy, patients are followed periodically for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed invasive breast cancer

- Stages I-IIIB with node-positive or -negative disease (N0-2)

- Operable disease

- Must meet 1 of the following criteria:

- Has undergone mastectomy or breast-conserving surgery with complete excision of
primary tumor within the past 8 weeks

- Scheduled to receive neoadjuvant chemotherapy

- No metastatic breast cancer, including supraclavicular fossa metastases

- Hormone receptor status meeting 1 of the following criteria:

- Estrogen receptor (ER) and progesterone receptor poor or negative AND not a
candidate for adjuvant endocrine therapy

- ER positive AND no requirement for ovarian suppression as a necessary part of


- Female

- Premenopausal with regular menses in the 12 months preceding surgery

- No other prior or concurrent invasive malignancy except adequately treated basal cell
or squamous cell skin cancer or carcinoma in situ of the cervix

- Suitable fitness status for chemotherapy

- Adequate hepatic, renal, and bone marrow function

- Not pregnant or nursing

- Fertile patients must use effective contraception


- See Disease Characteristics

- No prior chemotherapy or endocrine therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months

Principal Investigator

Robert C.F. Leonard, MD, BS, MB

Investigator Role:

Study Chair

Investigator Affiliation:

Charing Cross Hospital



Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Infertility
  • Menopausal Symptoms
  • menopausal symptoms
  • infertility
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-negative breast cancer
  • Breast Neoplasms
  • Infertility