Letrozole for Hormone Receptor-Positive Breast Cancer

Recruiting at 805 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: NSABP Foundation Inc

Must be taking: Aromatase inhibitors

Must not be taking: Sex hormones, Raloxifene

Disqualifiers: Osteoporotic fracture, Bilateral breast cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

3966 Participants Needed

Trial Summary

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.

Research Team

Norman Wolmark, MD

Principal Investigator

NSABP Foundation Inc

Eligibility Criteria

This trial is for postmenopausal women who have been disease-free since their initial breast cancer diagnosis and completed 57-63 months of hormone therapy. They must have had estrogen or progesterone receptor-positive tumors, undergone specific surgeries with axillary nodal staging, and be in good physical condition (ECOG status 0 or 1). Women on sex hormonal therapies or with certain health conditions are excluded.

Inclusion Criteria

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

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.)

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

Exclusion Criteria

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

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral letrozole or placebo once daily for up to 5 years

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 years

Annual visits

Treatment Details

Interventions

• Letrozole
• Placebo

Trial Overview The study is testing the effectiveness of Letrozole, a drug that lowers estrogen levels to treat hormone receptor-positive breast cancer, against a placebo. It's designed to see if continuing treatment with Letrozole after standard hormone therapy provides additional benefits.

Participant Groups

Group I: Group 2 Letrozole Experimental Treatment 1 Intervention

Patients receive oral letrozole once daily for up to 5 years.

Group II: Group 1 Placebo Placebo Group 1 Intervention

Patients receive oral placebo once daily for up to 5 years.

Letrozole is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Femara for:

• Breast cancer in postmenopausal women
• Increasing the chance of ovulation in women with polycystic ovary syndrome

Approved in European Union as Letrozole for:

• Early breast cancer in postmenopausal women
• Advanced breast cancer in postmenopausal women

Approved in Canada as Letrozole for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Who Is Running the Clinical Trial?

NSABP Foundation Inc

Lead Sponsor

Trials

89

Recruited

140,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania