Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

Stopped early · Phase 2

Conditions studied: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy

Key facts

Study ID: NCT01368263
Run by: Washington University School of Medicine
People needed: 8
Starts: 2011-09-01
Expected to finish: 2013-05-01
Last updated by the study team: 2015-04-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patient must have histological or cytological confirmed invasive breast cancer
Patient must be premenopausal confirmed by serum estradiol level in the premenopausal range (> 25 pg/ml) at the beginning of the study; for women on oral contraceptives, these agents must be held for two weeks before the estradiol assessment is made
Patient must have a negative serum pregnancy test within 7 days of registration
Patient's tumor must be ER+ with or without concomitant progesterone receptor-positive (PR+) with an Allred score of 6, 7 or 8; patients with > 66.6% of cells staining positive by conventional immunohistochemistry (IHC) have a minimum Allred score of 6 and are eligible
Patient's tumors must be HER2 negative by local laboratory assessment: HER2 IHC 0, 1+, or 2+ with subsequent negative fluorescent in situ hybridization (FISH) (ratio < 1.8); negative FISH alone in absence of IHC is acceptable
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (physical examination)
Patient's primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension
Patient must have mammogram and ultrasound of the breast within 42 days prior to registration; if a patient has clinically palpable or suspicious nodes, then an ultrasound of the axilla is also required
Patient, as documented by the treating physician, must be clinically staged as one of the following:
T4 a-c for which modified radical mastectomy with negative margins is the goal
T2 or T3 for which conversion from needing mastectomy to breast conservation is the goal
T2 for which lumpectomy at first attempt is the goal
Patient must be > or = 18 years old.
Patient must stop taking all forms of hormonal treatment, including oral or other form of hormonal contraceptive methods and all forms of hormone replacement therapy, at least two weeks prior to starting protocol therapy
Patient must agree to use a "highly-effective form of non-hormonal contraception" (applies to patient and/or partner)
Patient must be willing to undergo oophorectomy, if indicated
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Patient must have normal organ and marrow function as defined below:
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3.0 X institutional upper limit of normal (ULN)
Creatinine within normal institutional limits OR
Creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

You may not qualify if…

Patient must not have inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
Patient must not have had prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent; patients whose diagnosis was established by incision biopsy are not eligible
Patient must not have had prior DCIS in the ipsilateral breast
Patient must not have used tamoxifen for prior contralateral DCIS
Patient must not have any evidence of distant metastasis (M1) on imaging; staging scans are not mandatory but any exams performed as standard of care throughout the study period will be collected for correlation as needed
If patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant therapy, she is ineligible for this study
Patient must not be receiving other investigational agents or be enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
Pregnant and/or breastfeeding women are excluded from this study
Patient must not have any concurrent life threatening illnesses
Patient must not have undergone prior sentinel lymph node surgery; cores or FNA of lymph node are acceptable

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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