Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	Postmenopausal	NCI	ACOSOG-Z1031 CALGB-ACOSOG-Z1031, SDC1, NCT00265759

Special Category: NCI Web site featured trial, CTSU trial

Objectives

Primary

1. Determine whether anastrozole, exemestane, or letrozole administered for 16 to 18 weeks as neoadjuvant endocrine treatment for postmenopausal patients with stage II or stage III estrogen receptor (ER)-positive breast cancer should be chosen as the aromatase inhibitor arm of a future study that will compare neoadjuvant aromatase inhibitor (AI) treatment with neoadjuvant chemotherapy. (Cohort A)
2. To determine whether patients who have a high Ki-67 value (> 10%) after 2 weeks of neoadjuvant AI treatment experience a higher than expected pathological response rate to neoadjuvant chemotherapy (20%) than would be typically observed for postmenopausal patients with unselected ER+ rich tumors (estimated to be 5%), indicating that an early assessment of proliferation is a useful approach to the identification of a chemotherapy sensitive subgroup of ER+ tumors. (Cohort B [patients enrolled after the 375th patient])

Secondary

1. Compare the neoadjuvant treatment regimens relative to the rates of improvement in surgical outcome: mastectomy with primary skin closure and negative surgical margins (for T4 a, b, c tumors); breast conserving surgery with negative final margins (for T3 tumors and T2 tumors classified as requiring mastectomy at baseline); breast conserving surgery at first attempt (for T2 tumors classified as potential candidates for breast conservation).
2. Compare and confirm the radiological response rates (mammography and ultrasound by central radiological analysis) between these three neoadjuvant treatment regimens.
3. Compare the relative safety of the neoadjuvant treatment regimens in terms of reported adverse events.
4. To compare the tumor pathologic size between the neoadjuvant treatment regimens, to compare the rates of pathological complete response, and to compare down-staging to stage I.
5. To compare the rate of complete cell cycle response between the three treatment regimens (Ki67 staining of 1% or less in the post treatment sample).
6. Compare the incidence of metastatic lymph node involvement on the three arms of the study in patients who have a lymph node dissection at the end of neoadjuvant treatment.
7. Determine the 10-year incidence of local recurrence in patients treated with these regimens.
8. To collect tumor tissue, serum specimens, and plasma specimens to develop predictive biomarkers that can be used to select tumors for neoadjuvant AI therapy.
9. Collect surgical specimens post-AI neoadjuvant therapy to identify markers of de novo resistence to AI therapy.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer
  • T2-T4c, any N, M0 disease
• Clinically staged, as documented by the operating surgeon, as 1 of the following:
  • T4a-c disease for which modified radical mastectomy with negative margins is the goal
  • T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal
  • T2 disease for which lumpectomy at first attempt is the goal
• Primary tumor must be palpable and measure > 2 cm by tape, ruler, or caliper measurements in at least one dimension
• Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy
• No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
• No distant metastasis (M1)
  • Isolated ipsilateral supraclavicular node involvement allowed
• No diagnosis that was established by incisional biopsy
• Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8
  • Patients with > 66.66% (two-thirds) of cells staining positive and have a minimum Allred score of 6 are eligible

Prior/Concurrent Therapy:

• No prior treatment for invasive breast cancer, including radiotherapy, endocrine therapy, chemotherapy, or investigational agents
• No prior sentinel lymph node biopsy (cohort B only)
• At least 1 week since prior agents with estrogenic or putatively estrogenic properties, including herbal preparations
• At least 1 week since prior hormone replacement therapy of any type, megestrol acetate, or raloxifene
• No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer
• No other concurrent anti-neoplastic therapy, including chemotherapy or radiotherapy
• No concurrent agents or herbal products that alter ER function

Patient Characteristics:

• ECOG/Zubrod performance status of ≤ 2
• Female
• Patient must be postmenopausal, verified by 1 of the following:
  • Bilateral surgical oophorectomy
  • No spontaneous menses ≥ 1 year
  • No menses for < 1 year with FSH and estradiol levels in postmenopausal range
• No other malignancies within the past 5 years, except for successfully treated cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral ductal carcinoma in situ that was treated with mastectomy or lumpectomy with radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of recurrence
  • Must have undergone potentially curative therapy for all prior malignancies AND deemed to be at low risk for recurrence, according to the treating physician

Expected Enrollment

A total of 567 patients (375 for cohort A and 192 for cohort B) will be accrued for this study.

Outcomes

Clinical response (complete or partial response) rate (cohort A)
Pathological complete response rate to neoadjuvant chemotherapy (cohort B)

Radiological response rate
Adverse events as assessed by NCI CTCAE v3.0
Progression-free survival and overall survival
Rate of improvement in surgical outcome
Rate of downstaging to stage I
Rate of lymph node involvement
Pathological complete response rate (cohort A)
Clinical response rate (cohort B)

Outline

This is a multicenter study comprising cohort A (phase III study) and cohort B (phase II study). Once cohort A accrual is met (375 patients), subsequent patients are enrolled to cohort B. Patients in both cohorts are stratified according to T stage (T2 vs T3 vs T4), and randomized to 1 of 3 aromatase inhibition (AI) treatment arms.

• Arm I: Patients receive oral exemestane once daily for 16-18 weeks.
• Arm II: Patients receive oral letrozole once daily for 16-18 weeks.
• Arm III: Patients receive oral anastrozole once daily for 16-18 weeks.

Patients in cohort B undergo breast biopsy after 2-4 weeks of AI treatment for analysis of Ki-67 levels. Patients with Ki-67 level ≤ 10% continue AI treatment. Patients with Ki-67 level > 10% (high) are given the option to switch to neoadjuvant chemotherapy or undergo immediate breast surgery.

After completion of AI therapy, all patients undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection.

After surgery, patients are followed up periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Matthew Ellis, MD, PhD, FRCP, Protocol chair		Ph: 314-362-8903 Email: mellis@dom.wustl.edu
John Olson, MD, PhD, Protocol co-chair		Ph: 919-684-6523 Email: jaomd@duke.edu

Cancer and Leukemia Group B

Kevin Hughes, MD, FACS, Principal investigator		Ph: 617-724-4800 Email: kshughes@partners.org

U.S.A.
Alabama
	Mobile
	University of South Alabama Mitchell Cancer Institute
		Donna Dyess	Ph:  251-460-6993
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Palm Springs
	Desert Regional Medical Center Comprehensive Cancer Center
		Clinical Trials Office - Desert Regional Medical Center Comprehensive Cancer Center	Ph:  760-416-4730
Colorado
	Colorado Springs
	Memorial Hospital Cancer Center - Colorado Springs
		Clinical Trials Office - Memorial Hospital	Ph:  719-365-2406
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Juan Paramo	Ph:  305-674-2625
Georgia
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		John Kennedy, MD	Ph:  404-508-4320
	Gainesville
	Northeast Georgia Medical Center
		Pierce Dixon, MD	Ph:  770-531-0093
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		Mark Taylor, MD	Ph:  912-354-6187
	Valdosta
	Pearlman Comprehensive Cancer Center at South Georgia Medical Center
		Jeffrey Hoy, MD	Ph:  229-259-4628
Illinois
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
Indiana
	Munster
	Community Hospital
		Erwin Robin, MD	Ph:  219-836-2860
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
Kentucky
	Edgewood
	Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
		Joseph Guenther, MD	Ph:  513-961-4335
	Lexington
	Central Baptist Hospital
		Clinical Trials Office - Central Baptist Hospital	Ph:  859-260-6425
	Louisville
	Drs. Carrol, Sheth, Raghavan
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
Maine
	York
	York Hospital's Oncology Treatment Center
		Jonathan Eneman	Ph:  207-351-3777
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Diana Dickson-Witmer	Ph:  410-398-4000
	Towson
	Cancer Institute at St. Joseph Medical Center
		Michael Schultz	Ph:  410-337-1000
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-638-8265
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Josephine Ford Cancer Center at Henry Ford Hospital
		S. David Nathanson, MD	Ph:  313-916-2917
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Iron Mountain
	Dickinson County Healthcare System
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-479-5605
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		James Reilly, MD	Ph:  402-354-8163
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-384-0013
New Hampshire
	Exeter
	Center for Cancer Care at Exeter Hospital
		Danny Sims	Ph:  603-580-6636
New Jersey
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	Hematology Oncology Associates, PC
		Anne Wallace, MD	Ph:  858-822-6193
	New Mexico Cancer Center
		Anne Wallace, MD	Ph:  858-822-6193
	Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
		Anne Wallace, MD	Ph:  858-822-6193
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
	Santa Fe
	New Mexico Cancer Care Associates
		Clinical Trials Office - New Mexico Cancer Care Associates	Ph:  505-955-7910
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Daniel Guyton, MD	Ph:  330-344-6234
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Bowling Green
	Wood County Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cincinnati
	Bethesda North Hospital
		Joseph Guenther, MD	Ph:  513-961-4335
	Good Samaritan Hospital Cancer Treatment Center
		Joseph Guenther, MD	Ph:  513-961-4335
	Clyde
	North Coast Cancer Care - Clyde
		Paul Schaefer, MD	Ph:  419-479-5605
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Elyria
	Hematology Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lima
	Lima Memorial Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Maumee
	Northwest Ohio Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Luke's Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic - Oregon
		Paul Schaefer, MD	Ph:  419-479-5605
	Sandusky
	North Coast Cancer Care, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Vincent Mercy Medical Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic, Incorporated - Main Clinic
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Paul Mosca	Ph:  610-402-0500
	Sacred Heart Hospital
		Mark Gittleman, MD	Ph:  610-366-7333
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Darius Desai, MD	Ph:  610-954-2140
	Phoenixville
	Cancer Center at Phoenixville Hospital
		Carl Sharer, DO	Ph:  610-983-1800
	York
	York Cancer Center at Apple Hill Medical Center
		Ronald Hempling, MD	Ph:  717-741-8100
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Hilton Head Island
	Hilton Head Regional Medical Center
		Megan Baker Ruppel	Ph:  843-681-6122
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
Tennessee
	Nashville
	Baptist Hospital
		Pat Whitworth, MD	Ph:  615-284-8229
Texas
	Dallas
	Dallas Surgical Group
		Peter Beitsch, MD, FACS	Ph:  972-566-8039
	Parkland Memorial Hospital
		Ann Leitch, MD	Ph:  214-648-3039
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	UT Southwestern University Hospital - Zale Lipshy
		Ann Leitch, MD	Ph:  214-648-3039
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Laredo
	Doctor's Hospital of Laredo
		Gary Unzeitig, MD	Ph:  956-726-3691
	Lubbock
	Joe Arrington Cancer Research and Treatment Center
		Clinical Trials Office - Joe Arrington Cancer Research and Treatment Center	Ph:  806-725-8000
			Email: jaccresearch@covhs.org
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939
Washington
	Seattle
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		J. David Beatty, MD	Ph:  206-215-6400
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center	Ph:  920-320-2749
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Clinical Trials Office - Froedtert Hospital	Ph:  414-805-3666
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
Ireland
	Dublin
	Beaumont Hospital
		Arnold Hill, MD, MCh, FRCSI	Ph:  353-1-809-3760

Related Information

Featured trial article

Registry Information
Official Title		A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer
Trial Start Date		2006-01-09
Trial Completion Date		2019-08-03 (estimated)
Registered in ClinicalTrials.gov		NCT00265759
Date Submitted to PDQ		2005-09-27
Information Last Verified		2010-02-07
NCI Grant/Contract Number		CA76001

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