Status:
COMPLETED
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole, may stop the growth of ...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the proportion of women who have adequate estrone (E1) and estradiol (E2) suppression after 8-10 weeks of adjuvant anastrozole 10 mg once daily (ANA10) having had in...
Eligibility Criteria
Inclusion
- REGISTRATION-INCLUSION CRITERIA
- Disease characteristics:
- Histological confirmation of invasive breast carcinoma
- Stage I-III breast cancer
- Estrogen receptor (ER) positive disease according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as ER \>= 1% positive nuclear staining
- Completion of all planned cancer treatments prior to registration:
- Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)
- Adjuvant radiation therapy, if needed
- Neoadjuvant and/or adjuvant chemotherapy, if needed
- Post-menopausal defined as
- Age \>= 60 and amenorrhea \> 12 consecutive months OR
- Previous bilateral oophorectomy OR
- Age \< 60 and amenorrhea \> 12 consecutive months and documented follicle stimulating hormone (FSH) level within post-menopausal range according to institutional standard
- NOTE: Patients who did not meet these criteria at time of diagnosis and received pre-operative (neoadjuvant) or post-operative (adjuvant) chemotherapy will not be allowed to participate
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration)
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
- Platelet count \>= 70,000/mm\^3 (obtained =\< 14 days prior to registration)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 14 days prior to registration)
- Ability to swallow oral medication
- Provide written informed consent
- Willingness to provide mandatory blood specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- RE-REGISTRATION-INCLUSION CRITERIA
- Confirmation that baseline blood sample was drawn and submitted
- Blood estrogen levels after cycle 1 anastrozole (ANA1) must meet the following criteria:
- E1 \>= 1.3 pg/ml, AND
- E2 \>= 0.5 pg/ml
Exclusion
- REGISTRATION-EXCLUSION CRITERIA
- Pre-menopausal women receiving ovarian function suppression (goserelin, leuprolide, etc.)
- Stage IV (metastatic) breast cancer
- HER2 positive breast cancer as defined by
- HER2 immunohistochemistry (IHC) \>= 3+
- HER2/CEP17 \>= 2.0
- HER2/CEP17 \< 2.0 and average HER2 copy number of \>= 6.0 signals/cell
- Prior endocrine therapy for this breast cancer. Exceptions:
- Pre-operative aromatase therapy (anastrozole, letrozole, or exemestane) and last treatment was \>= 4 weeks prior to registration OR
- Pre-operative tamoxifen therapy and last treatment was \>= 12 weeks prior to registration
- Currently receiving any of the following cancer-directed therapies:
- Radiation therapy
- Systemic therapy such as chemotherapy (standard or investigational)
- Bisphosphonate therapy started \< 4 weeks prior to registration
- NOTE: If patient is currently on bisphosphonate therapy she must be on stable dose for \>= 4 weeks prior to registration. Patients not currently taking bisphosphonates will be allowed to start bisphosphonate therapy after completion of anastrozole (1 mg and 10 mg daily \[if given\]). Information regarding bisphosphonate therapy will be collected
- Current use of systemic or topical exogenous estrogen or progesterone (menopausal hormone replacement therapy \[HRT\])
- Prior ovarian function suppression (leuprolide, goserelin, etc.)
- Inability to provide informed consent
- History of contralateral ductal carcinoma in situ (DCIS) or invasive breast cancer
- NOTE: Exception allowed if
- Patient did not receive adjuvant endocrine therapy OR
- Patient received adjuvant endocrine therapy but has been off treatment for at least 6 months prior to registration
- Concurrent active malignancy or history of malignancy =\< 3 years prior to registration
- NOTE: Exceptions allowed for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, papillary thyroid cancer, or non-melanoma skin cancer
- Prior prevention therapy with an aromatase inhibitor or a selective estrogen receptor modulator (SERM). Exception: Therapy with a SERM (tamoxifen or raloxifene) is allowed if patient has been off treatment for \>= 6 months prior to registration
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04294225
Start Date
April 28 2020
End Date
December 12 2022
Last Update
January 28 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905