Letrozole After Tamoxifen in Treating Women With Breast Cancer

NCT00003140 | Completed Phase 3 DMC

• 13 other identifiers: MA17U10CA025224CAN-NCIC-MA17CALGB-49805E-JMA17EORTC-10983IBCSG-BIG97-01NCCTG-JMA17SWOG-JMA17JRF-Vor-Int-10NCCTG-CAN-MA17SWOG-CAN-MA17CDR0000065921
• Study Type: interventional
• Target: 5,187
• Locations: 2 countries
• Sites: 57

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  5 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral letrozole once daily.

Drug: letrozole

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily.

Other: placebo

Interventions

letrozole DRUG

Given orally

Also known as: Femara

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• North Central Cancer Treatment Group: collaborator
• ETOP IBCSG Partners Foundation: collaborator
• Eastern Cooperative Oncology Group: collaborator
• SWOG Cancer Research Network: collaborator
• Cancer and Leukemia Group B: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (57)

Lethbridge Cancer Centre

Lethbridge, Alberta, T1J 1W5, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

NRGH - Nanaimo Cancer Clinic

Nanaimo, British Columbia, V9S 2B7, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

The Vitalite Health Network - Dr. Leon Richard

Moncton, New Brunswick, E1C 8X3, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

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

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

The Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

Regional Cancer Program of the Hopital Regional

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Markham Stouffville Hospital

Markham, Ontario, L6B 1A1, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Peterborough Regional Health Centre

Peterborough, Ontario, K9H 7B6, Canada

Location

Algoma District Cancer Program

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

Location

Niagara Health System

St. Catharines, Ontario, L2R 7C6, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Univ. Health Network-The Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Trillium Health Centre - West Toronto

Toronto, Ontario, M9C 1A5, Canada

Location

Humber River Regional Hospital

Toronto, Ontario, M9N 1N8, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

PEI Cancer Treatment Centre,Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

Centre de Sante et de services sociaux de Gatineau

Gatineau, Quebec, J8P 7H2, Canada

Location

L'Hotel-Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUM - Hotel Dieu du Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

CHUM - Pavillon Saint-Luc

Montreal, Quebec, H3X 3J4, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

University Institute of Cardiology and

Québec, Quebec, G1V 4G5, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Christie's Hospital NHS Trust

Manchester, M2O 4BX, United Kingdom

Location

The Royal Marsden NHS Foundation Trust - Sutton

Surrey, SM2 5PT, United Kingdom

Location

Related Publications (32)

• Baum M. Adjuvant endocrine therapy in postmenopausal women with early breast cancer: where are we now? Eur J Cancer. 2005 Aug;41(12):1667-77. doi: 10.1016/j.ejca.2005.05.006.

  PMID: 16046117 BACKGROUND

• Baum M. Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Cancer Control. 2004 Jul-Aug;11(4):217-21. doi: 10.1177/107327480401100402.

  PMID: 15284712 BACKGROUND

• Booth CM, Pater JL, Goss PE. Identifying breast cancer patients most likely to benefit from aromatase inhibitor therapy after adjuvant tamoxifen. Cancer. 2007 May 1;109(9):1927-8; author reply 1928. doi: 10.1002/cncr.22613. No abstract available.

  PMID: 17354227 BACKGROUND

• Buzdar A, Chlebowski R, Cuzick J, Duffy S, Forbes J, Jonat W, Ravdin P. Defining the role of aromatase inhibitors in the adjuvant endocrine treatment of early breast cancer. Curr Med Res Opin. 2006 Aug;22(8):1575-85. doi: 10.1185/030079906X120940.

  PMID: 16870082 BACKGROUND

• Scott LJ, Keam SJ. Letrozole : in postmenopausal hormone-responsive early-stage breast cancer. Drugs. 2006;66(3):353-62. doi: 10.2165/00003495-200666030-00010.

  PMID: 16526826 BACKGROUND

• Vakaet L. Re: Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2006 Aug 16;98(16):1162; author reply 1162-3. doi: 10.1093/jnci/djj323. No abstract available.

  PMID: 16912269 BACKGROUND

• Wardley AM. Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17. Clin Breast Cancer. 2006 Feb;6 Suppl 2:S45-50. doi: 10.3816/cbc.2006.s.003.

  PMID: 16595026 BACKGROUND

• Goss PE, Ingle JN, Martino S, et al.: Outcomes of women who were premenopausal at diagnosis of early stage breast cancer in the NCIC CTG MA17 trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-13, 2009.

  RESULT

• Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Tu D. Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin Oncol. 2008 Apr 20;26(12):1948-55. doi: 10.1200/JCO.2007.11.6798. Epub 2008 Mar 10.

  PMID: 18332475 RESULT

• Ingle JN, Tu D, Pater JL, Muss HB, Martino S, Robert NJ, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE. Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended adjuvant therapy in early breast cancer: NCIC CTG MA.17. Ann Oncol. 2008 May;19(5):877-82. doi: 10.1093/annonc/mdm566. Epub 2008 Mar 10.

  PMID: 18332043 RESULT

• Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ, Shepherd LE, Pritchard KI, He Z, Goss PE. Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17. J Clin Oncol. 2008 Apr 20;26(12):1956-64. doi: 10.1200/JCO.2007.12.6334. Epub 2008 Mar 10.

  PMID: 18332474 RESULT

• Chapman JW, Meng D, Shepherd L, et al.: Competing causes of death in breast cancer extended adjuvant endocrine therapy: NCIC CTG MA.17. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-56, 2007.

  RESULT

• Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL; National Cancer Institute of Canada Clinical Trials Group MA.17. Efficacy of letrozole extended adjuvant therapy according to estrogen receptor and progesterone receptor status of the primary tumor: National Cancer Institute of Canada Clinical Trials Group MA.17. J Clin Oncol. 2007 May 20;25(15):2006-11. doi: 10.1200/JCO.2006.09.4482. Epub 2007 Apr 23.

  PMID: 17452676 RESULT

• Goss P: Breaking the 5-year barrier: results from the MA.17 extended adjuvant trial in women who have completed adjuvant tamoxifen treatment. [Abstract] European Journal of Cancer Supplements 4 (9): 10-5, 2006.

  RESULT

• Ingle JN, Tu D, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE. Duration of letrozole treatment and outcomes in the placebo-controlled NCIC CTG MA.17 extended adjuvant therapy trial. Breast Cancer Res Treat. 2006 Oct;99(3):295-300. doi: 10.1007/s10549-006-9207-y. Epub 2006 Mar 16.

  PMID: 16541302 RESULT

• Ingle J, Tu D, Shepherd L, et al.: NCIC CTG MA.17: intent to treat analysis (ITT) of randomized patients after a median follow-up of 54 months. [Abstract] J Clin Oncol 24 (Suppl 18): A-549, 2006.

  RESULT

• Moy B, Tu D, Shepherd LE, et al.: NCIC CTG MA.17: tolerability of letrozole among ethnic minority women. [Abstract] J Clin Oncol 24 (Suppl 18): A-6018, 305s, 2006.

  RESULT

• Pater JL, Tu D, Ingle JN, et al.: An evaluation of the early termination (ET) of MA.17 extended adjuvant therapy trial. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2081, S107-8, 2006.

  RESULT

• Perez EA, Josse RG, Pritchard KI, Ingle JN, Martino S, Findlay BP, Shenkier TN, Tozer RG, Palmer MJ, Shepherd LE, Liu S, Tu D, Goss PE. Effect of letrozole versus placebo on bone mineral density in women with primary breast cancer completing 5 or more years of adjuvant tamoxifen: a companion study to NCIC CTG MA.17. J Clin Oncol. 2006 Aug 1;24(22):3629-35. doi: 10.1200/JCO.2005.05.4882. Epub 2006 Jul 5.

  PMID: 16822845 RESULT

• Robert NJ, Goss PE, Ingle JN, et al.: Updated analysis of NCIC CTG MA.17 (letrozole vs. placebo to letrozole vs placebo) post unblinding. [Abstract] J Clin Oncol 24 (Suppl 18): A-550, 2006.

  RESULT

• Abetz L, Barghout V, Thomas S, et al.: Letrozole did not worsen quality of life relative to placebo in post-menopausal women with early breast cancer: results from the US subjects of the MA-17 study. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2047, 2005.

  RESULT

• Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. doi: 10.1093/jnci/dji250.

  PMID: 16145047 RESULT

• Goss PE, Ingle JN, Palmer MJ, et al.: Updated analysis of NCIC CTG MA.17 (letrozole vs. placebo to letrozole vs placebo) post unblinding. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-16, 2005.

  RESULT

• Goss PE, Ingle JN, Tu D: NCIC CTG MA17: disease free survival according to estrogen receptor and progesterone receptor status of the primary tumor. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2042, 2005.

  RESULT

• Ingle JN, Goss PE, Tu D: Analysis of duration of letrozole extended adjuvant therapy as measured by hazard ratios of disease recurrence over time for patients on NCIC CTG MA.17. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-17, 2005.

  RESULT

• Luk C, Goss P, Pritchard K, et al.: Determinants of preferences for starting extended adjuvant letrozole (L) in postmenopausal women following five years of tamoxifen. [Abstract] J Clin Oncol 23 (Suppl 16): A-642, 39s, 2005.

  RESULT

• Vachon CM, Ingle JN, Scott CG, et al.: Pilot study of changes in mammographic density in women treated with letrozole or placebo on NCIC CTG MA17. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-6005, 2005.

  RESULT

• Whelan TJ, Goss PE, Ingle JN, Pater JL, Tu D, Pritchard K, Liu S, Shepherd LE, Palmer M, Robert NJ, Martino S, Muss HB. Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol. 2005 Oct 1;23(28):6931-40. doi: 10.1200/JCO.2005.11.181. Epub 2005 Sep 12.

  PMID: 16157934 RESULT

• Goss PE, Ingle JN, Martino S, et al.: Updated analysis of the NCIC CTG MA.17 randomized placebo (P) controlled trial of letrozole (L) after five years of tamoxifen in postmenopausal women with early stage breast cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-847, 88s, 2004.

  RESULT

• Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.

  PMID: 14551341 RESULT

• Ethier JL, Anderson GM, Austin PC, Clemons M, Parulekar W, Shepherd L, Summers Trasiewicz L, Tu D, Amir E. Influence of the competing risk of death on estimates of disease recurrence in trials of adjuvant endocrine therapy for early-stage breast cancer: A secondary analysis of MA.27, MA.17 and MA.17R. Eur J Cancer. 2021 May;149:117-127. doi: 10.1016/j.ejca.2021.02.034. Epub 2021 Apr 11.

  PMID: 33853037 DERIVED

• Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016 Jul 21;375(3):209-19. doi: 10.1056/NEJMoa1604700. Epub 2016 Jun 5.

  PMID: 27264120 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

• James N. Ingle, MD

  Mayo Clinic

  STUDY CHAIR

• Monica Castiglione-Gertsch, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

• Nicholas J. Robert, MD

  Fairfax Northern Virginia Hematology Oncology, PC - Fairfax

  STUDY CHAIR

• Silvana Martino, DO

  Saint John's Cancer Institute

  STUDY CHAIR

• Hyman B. Muss, MD

  University of Vermont

  STUDY CHAIR

• Martine J. Piccart-Gebhart, MD, PhD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: August 24, 1998
• Primary Completion: August 22, 2003
• Study Completion: October 1, 2003
• Last Updated: March 27, 2026

Record last verified: 2012-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (53); GB (4)