Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer

Overview

About this study

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 tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Registration:

  • Women of age ≥ 18 years.
  • Histological confirmation of invasive breast carcinoma.
  • Stage I-III breast cancer
  • Estrogen receptor (ER) positive disease according to ASCO/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; and
    • neoadjuvant and/or adjuvant chemotherapy, if needed.
  • Post-menopausal defined as
  • Age ³60 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.
  • ECOG Performance Status (PS) 0, 1, or 2 .
  • The following laboratory values obtained ≤14 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 70,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN.
  • 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).

Exclusion Criteria - Registration:

 

  • Pre-menopausal women receiving ovarian function suppression (goserelin, leuprolide, etc.).
  • Stage IV (metastatic) breast cancer.
  • HER2 positive breast cancer as defined by:
    • HER2 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 (1mg 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 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 SERM.
  • Exception: Therapy with a SERM (tamoxifen or raloxifene) is allowed if patient has been off treatment for ≥ 6 months prior to registration.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Tufia Haddad, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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