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New hope for breast cancer survivors: letrozole extends remission

NCT ID NCT00003140

Disease control Sponsor: NCIC Clinical Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether taking letrozole, a hormone-blocking drug, could help prevent breast cancer from coming back in women who had already taken tamoxifen for at least 5 years. Over 5,000 women participated, and researchers measured how long they stayed cancer-free. The goal was to see if letrozole offers extra protection after tamoxifen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

5,187 people

The number who actually took part.

Started

Aug 1998

Finished

Oct 2003

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 120 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis * No ductal carcinoma in situ * Axillary lymph node negative, positive, or unknown * No evidence of metastases * No localized or distant breast cancer recurrence * Not registered on protocol NCCTG-893052, any other IBCSG protocol, or protocol SWOG-S9623 * Hormone receptor status: * Estrogen or progesterone receptor positive as defined by tumor receptor content at least 10 fmol/mg protein or receptor positive by ERICA or PgRICA * Unknown status allowed if effort to determine status has been made by immunocytochemistry * No contralateral breast cancer PATIENT CHARACTERISTICS: Age: * Postmenopausal Sex: * Female Menopausal status: * Postmenopausal defined by one of the following: * Age 50 or over at start of adjuvant tamoxifen * Under age 50 and considered postmenopausal by treating physician at start of adjuvant tamoxifen * Under age 50 at start of adjuvant tamoxifen and had bilateral oophorectomy (surgical or radiation) * Under age 50 and premenopausal at start of adjuvant tamoxifen, but became amenorrheic during tamoxifen and remained amenorrheic for at least 1 year * Considered postmenopausal by physician with LH/FSH levels under the treatment center's postmenopausal limits Performance status: * ECOG 0-2 Life expectancy: * At least 5 years Hematopoietic: * WBC ≥ 3,000/mm\^3 OR * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic: * AST and/or ALT \< 2 times upper limit of normal (ULN) (unless imaging examinations have ruled out metastatic disease) * Alkaline phosphatase \< 2 times ULN (unless imaging examinations have ruled out metastatic disease) Renal: * Not specified Other: * No concurrent medical or psychiatric condition that would preclude study participation * No other malignancy within the past 5 years except adequately treated superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * Able to swallow study drug * Adequate oral intake PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant chemotherapy allowed * No concurrent chemotherapy Endocrine therapy: * Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection * Completed at least 4.5-6 years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen * No more than 3 months since prior adjuvant tamoxifen * No concurrent hormone replacement therapy (e.g., megestrol) * No concurrent selective estrogen-receptor modulators (e.g., raloxifene or idoxifene) * Concurrent intermittent vaginal estrogens (e.g., Estring) allowed if other local measures for intractable vaginal atrophy are insufficient * No other concurrent aromatase inhibitors * No more than 2 years since prior aromatase inhibitor therapy (re-randomization) Radiotherapy: * Prior radiotherapy allowed Surgery: * See Disease Characteristics Other: * At least 1 month since prior investigational drugs * Prior treatment on a clinical trial for breast cancer allowed if permission has been obtained from the sponsors of the original study for their patient to participate on MA.17/JMA.17/BIG-97-01 * No prior placebo on core protocol * No concurrent anticancer therapy * Concurrent thyroid medication, calcium, vitamin D, and bisphosphonates allowed

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8, Canada

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2, Canada

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2, Canada

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5, Canada

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1, Canada

  • CHUM - Hotel Dieu du Montreal

    Montreal, Quebec, H2W 1T8, Canada

  • CHUM - Pavillon Saint-Luc

    Montreal, Quebec, H3X 3J4, Canada

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6, Canada

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre de Sante et de services sociaux de Gatineau

    Gatineau, Quebec, J8P 7H2, Canada

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Christie's Hospital NHS Trust

    Manchester, M2O 4BX, United Kingdom

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1, Canada

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, AIB 3V6, Canada

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5, Canada

  • Humber River Regional Hospital

    Toronto, Ontario, M9N 1N8, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2, Canada

  • L'Hotel-Dieu de Levis

    Lévis, Quebec, G6V 3Z1, Canada

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9, Canada

  • Lethbridge Cancer Centre

    Lethbridge, Alberta, T1J 1W5, Canada

  • London Regional Cancer Program

    London, Ontario, N6A 4L6, Canada

  • Markham Stouffville Hospital

    Markham, Ontario, L6B 1A1, Canada

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • NRGH - Nanaimo Cancer Clinic

    Nanaimo, British Columbia, V9S 2B7, Canada

  • Niagara Health System

    St. Catharines, Ontario, L2R 7C6, Canada

  • North York General Hospital

    Toronto, Ontario, M2K 1E1, Canada

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6, Canada

  • PEI Cancer Treatment Centre,Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5, Canada

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6, Canada

  • Peterborough Regional Health Centre

    Peterborough, Ontario, K9H 7B6, Canada

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Regional Cancer Program of the Hopital Regional

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • St. Joseph's Health Centre

    Toronto, Ontario, M6R 1B5, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9, Canada

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8, Canada

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust - Sutton

    Surrey, SM2 5PT, United Kingdom

  • The Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2, Canada

  • The Vitalite Health Network - Dr. Leon Richard

    Moncton, New Brunswick, E1C 8X3, Canada

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7, Canada

  • Trillium Health Centre - West Toronto

    Toronto, Ontario, M9C 1A5, Canada

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Univ. Health Network-The Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • University Institute of Cardiology and

    Québec, Quebec, G1V 4G5, Canada

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3, Canada

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

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