Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: exemestane; tamoxifen; triptorelin
Intervention MeSH terms: Tamoxifen; Triptorelin Pamoate; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2672.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer

Summary:

      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of
      estrogen. It is not yet known whether giving triptorelin together with exemestane is more
      effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

      PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how
      well they work compared to triptorelin and tamoxifen in treating premenopausal women with
      hormone-responsive breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

          -  Completely resected disease

               -  No clinically detectable residual loco-regional axillary disease

               -  Prior surgery for primary breast cancer of 1 of the following types:

                    -  Total mastectomy with or without adjuvant radiotherapy

                    -  Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial
                       mastectomy with margins negative* for invasive disease and ductal carcinoma
                       in situ) with planned radiotherapy NOTE: *If all other margins are clear a
                       positive posterior (deep) margin is permitted, provided the excision was
                       performed down to the pectoral fascia and all tumor has been removed OR a
                       positive anterior (superficial; abutting skin) margin is allowed provided
                       all tumor was removed

          -  Tumor confined to the breast and axillary nodes

               -  Tumor detected in internal mammary chain nodes by sentinel node procedure and is
                  not enlarged is allowed

          -  Axillary lymph node dissection or a negative axillary sentinel node biopsy required

               -  Patients with negative or microscopically positive axillary sentinel nodes are
                  eligible

               -  Positive sentinel nodes must have either axillary dissection or radiation of
                  axillary nodes

          -  No distant metastases

          -  No locally advanced inoperable breast cancer, including any of the following:

               -  Inflammatory breast cancer

               -  Supraclavicular node involvement

               -  Enlarged internal mammary nodes (unless pathologically negative)

          -  Bilateral synchronous invasive breast cancer allowed if disease meets all other
             eligibility criteria

          -  No prior ipsilateral or contralateral invasive breast cancer

          -  Hormone receptor status:

               -  Estrogen and/or progesterone receptor positive

                    -  At least 10% of the tumor cells positive by immunohistochemistry

                    -  If > 1 breast tumor, each tumor must be hormone receptor positive

        PATIENT CHARACTERISTICS:

        Age

          -  Premenopausal

        Sex

          -  Female

        Menopausal status

          -  Premenopausal

               -  Estradiol in the premenopausal range after prior surgery OR meets the following
                  criteria:

                    -  Menstruating regularly for the past 6 months

                    -  Has not used any form of hormonal treatment (including hormonal
                       contraception) within the past 6 months

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  No systemic hepatic disease that would preclude prolonged follow-up

        Renal

          -  No systemic renal disease that would preclude prolonged follow-up

        Cardiovascular

          -  No systemic cardiovascular disease that would preclude prolonged follow-up

          -  No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is
             medically suitable

        Pulmonary

          -  No systemic pulmonary disease that would preclude prolonged follow-up

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective nonhormonal contraception

          -  No history of noncompliance to medical regimens

          -  No other nonmalignant systemic disease that would preclude prolonged follow-up

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral
             carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy,
             including any of the following:

               -  Stage I papillary thyroid cancer

               -  Stage IA carcinoma of the cervix

               -  Stage IA or B endometrioid endometrial cancer

               -  Borderline or stage I ovarian cancer

          -  No psychiatric, addictive, or other disorder that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed

        Chemotherapy

          -  No prior neoadjuvant or adjuvant chemotherapy

        Endocrine therapy

          -  No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g.,
             raloxifene), or hormone replacement therapy for more than 1 year before breast cancer
             diagnosis

          -  No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer

          -  No concurrent oral or transdermal hormonal therapy

          -  No other concurrent estrogen, progesterone, or androgens

          -  No other concurrent aromatase inhibitors

          -  No concurrent oral or other hormonal contraceptives (i.e., implants or depot
             injections)

        Radiotherapy

          -  See Disease Characteristics

          -  No prior ovarian radiotherapy

        Surgery

          -  See Disease Characteristics

          -  No prior bilateral oophorectomy

        Other

          -  No concurrent bisphosphonates, except in the following cases:

               -  Bone density is at least 1.5 standard deviations below the young adult normal
                  mean

               -  Participation in a randomized clinical study testing bisphosphonates in the
                  adjuvant breast cancer setting

          -  No other concurrent investigational agents