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A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen F

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Eligibility Criteria

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1 (0 = fully active, able to carry on all pre-disease performance without
restriction; 1 = restricted in physically strenuous activity but ambulatory).

- Patients must be postmenopausal at the time of randomization. (Note: Premenopausal or
perimenopausal women requiring therapy with luteinizing hormone-releasing hormone
[LHRH] analogs to suppress ovarian function are not eligible.) For study purposes,
postmenopausal is defined as: age 56 or older with no spontaneous menses for at least
12 months prior to study entry, or age 55 or younger with no spontaneous menses for
at least 12 months prior to study entry (e.g., spontaneous or secondary to
hysterectomy) AND with a documented estradiol level in the postmenopausal range
according to local institutional/laboratory standards, or a prior documented
bilateral oophorectomy.

- The patient must have remained disease-free from the time of initial breast cancer
diagnosis until the time of randomization.

- The patient must have had histologically-confirmed invasive carcinoma of the breast
by diagnostic core needle biopsy or by final pathologic evaluation of the surgical

- Patients who received neoadjuvant chemotherapy must have been clinical Stage I, II,
or IIIA. For patients who received adjuvant chemotherapy, the primary tumor must have
been T1-3 on pathologic evaluation and ipsilateral nodes must have been pN0, pN1
(pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.

- The primary tumor must have been estrogen receptor (ER)-positive and/or progesterone
receptor (PgR)-positive. (Patients who had a tumor that was considered to be
borderline for hormone receptor positivity and who were treated with tamoxifen and/or
an aromatases inhibitor (AI) are eligible for this study.)

- Patients must have undergone either a lumpectomy with axillary nodal staging followed
by breast radiotherapy or a total mastectomy with axillary nodal staging. (Acceptable
axillary nodal staging procedures include sentinel node biopsy alone, if sentinel
nodes were negative on hematoxylin and eosin (H&E) staining.)

- The duration of the patient's hormonal therapy following breast cancer diagnosis must
have been 57-63 months from the first dose regardless of the number of missed doses.
Hormonal therapy must have consisted of an AI or a combination of up to 3 years of
tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 and 5
of the 5 years of adjuvant hormonal therapy. (Note: Patients must discontinue their
adjuvant AI therapy at the time of randomization.)

- Optional Letrozole Registration Program for patients who have not yet completed 5
years of hormonal therapy. (Note: As of September 5, 2008, the optional NSABP B-42
Registration Program closed to patient enrollment. Accrual and data collection for
the NSABP B-42 randomized treatment trial continues as planned.) In order to have a
predominantly letrozole-treated population for B-42 study entry, patients who have
had a minimum of 2 years of hormonal therapy and who are currently on tamoxifen (for
up to 3 years) or an AI may be offered letrozole at no cost until they complete 5
total years of initial adjuvant hormonal therapy.

- B-42 randomization must be within 6 months following completion of 5 years (57-63
months) of initial adjuvant hormonal therapy.

- At the time of randomization, the patient must have had the following: history and
physical exam within 3 months demonstrating no findings suggestive of recurrent
breast cancer; bilateral mammogram within 1 year (unilateral if patient had a
mastectomy); mammogram not required if patient had a prophylactic contralateral
mastectomy; bone mineral density (BMD) testing within 1 year; and fasting lipid
profile (total cholesterol, LDL-C, HDL-C, and triglycerides) with a total cholesterol
value less than or equal to grade 1 (according to CTCAE v3.0), with or without
cholesterol-lowering therapy.

- within 1 year if the patient has a history of hypercholesterolemia controlled
with cholesterol-lowering therapy and/or therapeutic lifestyle changes or if the
patient has a history of one or more of the following risk factors for future
cardiovascular events: diabetes, hypertension, obesity, tobacco use,
hypertriglyceridemia, documented coronary artery disease, or family history of
premature coronary heart disease.

- within 2 years for all other patients.

Ineligibility Criteria

- Patients with one or more of the following conditions will be ineligible for this

- History of non-traumatic osteoporotic fracture of wrist, hip, or spine.

- Diagnosis of bilateral breast cancer including ductal carcinoma in situ
(DCIS)[(synchronous or metachronous].

- Other malignancies unless the patient is considered to be disease-free for 5 or more
years prior to randomization, and is deemed by their physician to be at low risk for
recurrence. Patients with the following cancers are eligible if diagnosed and treated
within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ,
melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

- Sex hormonal therapy, e.g., estrogen- or progesterone-replacement therapy or oral
contraceptives. These patients are eligible only if this therapy is discontinued
prior to randomization.

- Therapy with any hormonal agent such as raloxifene for management of osteoporosis.
Patients are eligible only if these medications are discontinued prior to study

- Administration of any investigational agent within 30 days before study entry.

Gender: Female
Steward Physician(s)
  • Norman Wolmark, MD
  • Saint Anne's Hospital - Active, not recruiting
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
  • Letrozole
  • Placebo
Physician Researcher

Investigator Name:

  • Norman Wolmark, MD

Other Information

Sponsor: NSABP Foundation Inc
Phase: Phase 3
Trial ID: NCT00382070
Volunteers:  Not Accepting Healthy Volunteers

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