In This SectionTexas Health Research & Education Institute
Disease or Condition
P622 NSABP B-33 (Breast Cancer)
Patients will be randomized to one of two groups:
Group 1: Patients will receive exemestane (brand name Aromasin®). Patients will take exemestane tablets by mouth once a day for 5 years.
Group 2: Patients will receive a placebo. Patients will take the tablets by mouth once a day for 5 years.
Patients must consent to be in the study and must have signed and dated an IRB- approved consent form conforming to federal and institutional guidelines
The patient should have received tamoxifen thereapy for a total of 57-66 months.
The interval between completion of tamoxifen therapy and randomization must be no more than 180 days.
Patients must have previously indergone either a total mastectomy and axillary dissection (modified radical mstectomy) or lumpectomy and axillary dissection. PAtients who have sentienl node biopsies are eligible under the following circumstances:
a. If they are not registered on NSABP b-32, they must have had a sentinel node biopsy and complete axillary dissection.
b. If they are registered on NSABP b-32 and they have a pathologically positive sentinel node or a sentinel node that is not identified by blue dye or radioactive tracer, they must have a completed axillary dissection to be eligible. Resceted margins must be clear of invasive tumor and ductal carcinoma in situ (DCIS).
Patients must have a life expactancy of atleast 10 years, excluding their diagnosis of cancer, and must be disease free at the time of randomization.
At the time of original diagnosis and treatement, the tumor must have been confined to the breast and ipsilateral axilla on clinical examination (T1-3 N0-1 M0). See Appendix B for staging information.
The original tumor must be incasive adenocarcinoma by histologic examination.
The resected axillary luymph nodes may or may not demonstrate evidence of tumor by histologic examination.
A the time of randomization, patients must have the following evaluations:
a. History and physical examination (within 1 year before randomization).
b. Chest xray (within 1 year before randomization).
c. Blood work (within 3 months before randomization).
i. Serum creatinine ≤ 1.5 x institutional upper limit of normal [ULN].
ii. Hemoglobin within noraml limits (WNL) for institution.
iii. Absolute granulocyte count (AGC) must be ≥ 1500 ( or <1500, if the opinion of the ivestigatior, this represents an ethnic or racial variation of normal).
iv. Platelet count ≥ 100,00.
d. Adequate hepatic function (all within 3 months before randomization).
i. Either SGOT (AST0 or SGPT (ALT) ≤ 2.5 x ULN.
ii. Total bilirubin < 2 x the upper limit of normal (UNL) for the lboratory.
iii. Alkaline phosphate < 2 x the ULN.
e. For women who have an intact uterus a gyneologic exam within 1 year before randomization.
f. A bilatereal mammogram, or for patients with a mastectomy, a unilateral mammogramwithin 1 year before randomization.
Patients must have determinations of both estrogen and progesterone receptors performed on the primary tumor art the time of the original resection. ( See section 6.0). The primary tumor must be ER-positive (defined as as ≥ 10 fmol/mg cytosol protien by the dextran - coated charcoal or sucrose-density gradient method, or positive [using individual laboratory criteria] by the enzyme immunassy method [EIA], or by immunoytochemical assay) and/or PgR-positive (i.e. ER+PgR-, ER+Pgr+, Er - Pgr+). Patients who have tumors that were considered to be borderline for ER positivity but who were treated with tamoxifen are eligible for this study.
Patients may have received prior adjuvant chemotherapy wither concomaitant with or before initation of their tamoxifen therapy. They may have received post-mastectomy local-regional raiotherapy or post-lumpectomy regional raiotherapy. Patients who underwent lumpectomy must have reveived breast irradiation post-lumpectomy.
Patients must be postmenopausal at the time of randomization. For study purposes, postmenopausal status requires a previous bilateral spontaneous menstrul cycle for more than 1 year.
Women <55 years old who have a hysterectomy but not a bilateral oophorectomy should have an FSH within the postmenopausal range as determined by the investigator.
All patients registered to NSABP Protocol B-33 at sites that have been selected to participate in the BBL substudy should be evalutaed for the BBL substudy. (Please see Appendix A for BBL substudy). However, patients eligible for the BBL substudy who choose to participate in the substudy may still participate in NSABP B-33.
Patients who were enrolled in any other NSABP adjuvant study may participate in NSABP B-33 as long as the previous trial was reported in an article appearing in a peer reviewed publication or tamoxifen was not a test question in the trial.
Male patients are not eligible for this study. Patients with one or more of the following conditions will be ineligible for this study.
Breast cancer patients who have experienced a local, regional, or distant reccurrence or a second primary breast malignancy (Including contralateral breast cancer) prior to randomization into the study.
Bilateral malignancy or mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant.
Patients who are premenopausal or perimenopausal.
Patients who had any clinical sign of advanced disease at the time of the original diagnosis, i.e. ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration; patients with these conditions are eligible.)
Patients who had ipsilateral lymph nodes that were clinically fixed to one another or to other structures (cN2 disease) at the time of the original dianosis.
Patients who have nonmalignant systemic disease (cariovascular, renal, heptic, ect.) that would preclude their being subjected to protocol therapy or would prevent long term follow-up.
Patients who have psychiatric or addictive disorders that would preclude obtaining informed consent.
Patients currently taking systemic hormaonal agents (other than Estring or estrogen vaginal cream at 3.0 mg or 1/8 of an applicator, applied vaginally 3 times each week), e.g. tamoxifen or ralocifene.
Patients with tamoxifen with tumors that wre ER-negative and PgR-negative.