Breast Cancer Cancer Breast Cancer
Conditions
Interventions
Treatment A: Chemotherapy
Treatment B: Chemotherapy plus Goserelin
Sponsors
Clinical Trials Advisory and Awards Committee (CTAAC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Disease characteristics: 1. Histologically confirmed invasive breast cancer 2. Stages I-IIIB with node-positive or -negative disease (N0-2) 3. Operable disease 4. Must meet one of the following criteria: 4.1. Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past eight weeks 4.2. Scheduled to receive neoadjuvant chemotherapy 4.3. No metastatic breast cancer, including supraclavicular fossa metastases 4.4. Hormone receptor status meeting one of the following criteria: 4.4.1. Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy 4.4.2. ER positive AND no requirement for ovarian suppression as a necessary part of treatment Patient characteristics: 1. Female 2. Premenopausal with regular menses in the 12 months preceding surgery 3. No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix 4. Suitable fitness status for chemotherapy 5. Adequate hepatic, renal, and bone marrow function 6. Not pregnant or nursing 7. Fertile patients must use effective contraception
Exclusion criteria
Exclusion criteria: Prior chemotherapy or endocrine therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of menopausal symptoms 2. Quality of life 3. Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers 4. Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course three, after course six or eight (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to five years 5. Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy 6. Incidence of pregnancy | — |
Countries
United Kingdom, Wales
Outcome results
None listed