Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 1/11/2019 |
Start Date: | August 2006 |
End Date: | December 2019 |
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 Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
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.
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.
OBJECTIVES:
Primary
- Determine whether or not prolonged adjuvant hormonal therapy comprising letrozole vs
placebo will improve disease-free survival of postmenopausal women with estrogen
receptor-positive and/or progesterone receptor-positive breast cancer who have completed
5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a
combination of up to 3 years of tamoxifen citrate followed by an AI.
- Compare the disease-free survival of patients treated with these regimens.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare breast cancer-free interval of patients treated with these regimens.
- Compare distant recurrence in patients treated with these regimens.
- Compare the incidence of osteoporotic-related fractures (e.g., Colles', hip, and spine)
in these patients treated with these regimens.
- Compare the incidence of arterial thrombotic events in patients treated with these
regimens.
OUTLINE: This is a double-blind, multicenter, placebo-controlled, randomized study. Patients
are stratified according to pathologic nodal status (negative vs positive), adjuvant
tamoxifen citrate therapy (yes vs no), and lowest bone mineral density T score for
lumbosacral spine, total hip, or femoral neck (> -2.0 vs ≤ -2.0 standard deviation). Patients
are randomized to 1 of 2 treatment arms.
- Group I: Patients receive oral placebo once daily.
- Group II: Patients receive oral letrozole once daily.
In both arms, treatment continues for up to 5 years in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 3,840 patients will be accrued for this study.
Primary
- Determine whether or not prolonged adjuvant hormonal therapy comprising letrozole vs
placebo will improve disease-free survival of postmenopausal women with estrogen
receptor-positive and/or progesterone receptor-positive breast cancer who have completed
5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a
combination of up to 3 years of tamoxifen citrate followed by an AI.
- Compare the disease-free survival of patients treated with these regimens.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare breast cancer-free interval of patients treated with these regimens.
- Compare distant recurrence in patients treated with these regimens.
- Compare the incidence of osteoporotic-related fractures (e.g., Colles', hip, and spine)
in these patients treated with these regimens.
- Compare the incidence of arterial thrombotic events in patients treated with these
regimens.
OUTLINE: This is a double-blind, multicenter, placebo-controlled, randomized study. Patients
are stratified according to pathologic nodal status (negative vs positive), adjuvant
tamoxifen citrate therapy (yes vs no), and lowest bone mineral density T score for
lumbosacral spine, total hip, or femoral neck (> -2.0 vs ≤ -2.0 standard deviation). Patients
are randomized to 1 of 2 treatment arms.
- Group I: Patients receive oral placebo once daily.
- Group II: Patients receive oral letrozole once daily.
In both arms, treatment continues for up to 5 years in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 3,840 patients will be accrued for this study.
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
specimen.
- 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
study:
- 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 entry.
- Administration of any investigational agent within 30 days before study entry.
We found this trial at
778
sites
3700 California Street
San Francisco, California 94118
San Francisco, California 94118
(415) 600-6000
California Pacific Medical Center - California Campus California Pacific Medical Center is one of the...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
(610) 402-8000
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Lehigh Valley Hospital provides a...
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417 State St #30
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7478
CancerCare of Maine at Eastern Maine Medical Center Our compassionate, experienced physicians specialize in the...
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Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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Olympic Hematology and Oncology We provide outpatient cancer services in a refined environment designed specifically...
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1300 Morris Park Avenue
Bronx, New York 10461
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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115 Business loop 70 w
Columbia, Missouri 65203
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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1719 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
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1376 Mowry Road
Gainesville, Florida 32610
Gainesville, Florida 32610
(352) 273-8010
University of Florida Shands Cancer Center We are the University of Florida Health Cancer Center
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1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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600 Moye Boulevard
Greenville, North Carolina 27834
Greenville, North Carolina 27834
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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85 Retreat Ave # 2
Hartford, Connecticut 06102
Hartford, Connecticut 06102
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
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Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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St. Vincent Indianapolis Hospital At St.Vincent Indianapolis, everything we do begins with a focus on...
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1900 South Avenue
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
(608) 782-7300
Gundersen Lutheran Center for Cancer and Blood Gundersen Health System is where caring meets excellence...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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800 Rose St
Lexington, Kentucky 40536
Lexington, Kentucky 40536
(859) 257-4488
Lucille P. Markey Cancer Center at University of Kentucky The Markey Cancer Center was founded...
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11234 Anderson Street
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4126
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda University Cancer...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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701 West 168th Street
New York, New York 10032
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
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985950 Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Comprehensive Cancer Center The Comprehensive Cancer Center at Rhode Island Hospital is...
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401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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4700 Waters Avenue
Savannah, Georgia 31404
Savannah, Georgia 31404
912-350-8490
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center The Curtis and...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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747 Broadway
Seattle, Washington 98122
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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1717 S J St
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 426-4101
Franciscan Cancer Center at St. Joseph Medical Center St. Joseph Medical Center is a 361-bed...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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401 West Poplar Street
Walla Walla, Washington 99362
Walla Walla, Washington 99362
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Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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