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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00310180




Registration number
NCT00310180
Ethics application status
Date submitted
29/03/2006
Date registered
3/04/2006
Date last updated
13/11/2024

Titles & IDs
Public title
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
Scientific title
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
Secondary ID [1] 0 0
NCI-2009-00707
Secondary ID [2] 0 0
NCI-2009-00707
Universal Trial Number (UTN)
Trial acronym
TAILORx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Adenocarcinoma 0 0
Hormone Receptor Positive 0 0
Stage IA Breast Cancer AJCC v7 0 0
Stage IB Breast Cancer AJCC v7 0 0
Stage IIA Breast Cancer AJCC v6 and v7 0 0
Stage IIB Breast Cancer AJCC v6 and v7 0 0
Stage IIIB Breast Cancer AJCC v7 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Anastrozole
Treatment: Drugs - Exemestane
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Letrozole
Other interventions - Quality-of-Life Assessment
Treatment: Other - Radiation Therapy
Treatment: Drugs - Tamoxifen Citrate

Experimental: Group 1 (Oncotype DX recurrence score =< 10) - Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.

Experimental: Group 2, Arm I (experimental) - Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.

Active comparator: Group 2, Arm II (standard) - Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.

Experimental: Group 3 (Oncotype DX recurrence score >= 26) - Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.


Treatment: Drugs: Anastrozole
Given PO

Treatment: Drugs: Exemestane
Given PO

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Letrozole
Given PO

Other interventions: Quality-of-Life Assessment
Ancillary studies

Treatment: Other: Radiation Therapy
Undergo radiation therapy or partial breast irradiation

Treatment: Drugs: Tamoxifen Citrate
Given PO
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year Disease-free Survival
Timepoint [1] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
Secondary outcome [1] 0 0
5-year Distant Recurrence-free Interval
Timepoint [1] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years
Secondary outcome [2] 0 0
5-year Recurrence-free Interval
Timepoint [2] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years
Secondary outcome [3] 0 0
5-year Overall Survival
Timepoint [3] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years
Secondary outcome [4] 0 0
5-year Disease-free Survival by Age and Recurrence Score Groups
Timepoint [4] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
Secondary outcome [5] 0 0
To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test
Timepoint [5] 0 0
Assessed at 10 years after study entry
Secondary outcome [6] 0 0
5-year Disease-free Survival by Individual RS Gene Groups
Timepoint [6] 0 0
Assessed every 6 months within 5 years from registration and then annually up to 20 years

Eligibility
Key inclusion criteria
* Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria:

* ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone receptor positive disease (as defined by local pathology laboratory)
* Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an axillary dissection, or both, and as defined by the Sixth Edition of the American Joint Committee on Cancer (AJCC) staging criteria
* Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features):

* Unfavorable features defined as intermediate or poor nuclear and/or histologic grade, or lymphovascular invasion
* NOTE: Definition of tumor size: The tumor size used for determination of eligibility is the pathologic tumor size, which is usually determined by the size of the tumor as measured by inspection of the gross specimen; if the tumor size is measured microscopically and the tumor includes ductal carcinoma in-situ, the measurement should include only the invasive component of the tumor
* The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative by either fluorescent in-situ hybridization (FISH) or immunohistochemistry (e.g. 0 or 1+ by DAKO Herceptest)
* The patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy
* A tissue specimen from the primary breast cancer has been located and is ready to be shipped to the appropriate laboratory after consent is obtained and within 3 days following pre-registration; NOTE: For determination of the Oncotype Recurrence Score, tissue must be shipped to Genomic Health; if the Oncotype DX Recurrence Score was previously performed by Genomic Health (prior to pre-registration), tissue must be submitted to the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility upon randomization
* Leukocyte count >= 3500/mm^3
* Platelets >= 100,000/mm^3
* Serum creatinine =< 1.5 mg/dL
* Serum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits of normal
* Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a previous ipsilateral or contralateral invasive breast cancer, or with bilateral synchronous cancers, are not eligible; patients with previous ipsilateral or contralateral ductal in situ carcinoma (DCIS) are not eligible
* Prior treatment

* Mandatory prior surgery criteria:

* Patient must pre-register within 84 days from the final surgical procedure required to adequately treat the primary tumor (please note that if margins are not clear and a resection has to be conducted after pre-registration but before randomization, the patient will be deemed to be within the 84 day window allowed by protocol and therefore eligible)
* All tumors should be removed by either a mastectomy or local excision plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy, axillary dissection, or both); there must be adequate (at least 1 mm if margin width specified) tumor-free margins of resection (for invasive and ductal carcinoma in-situ) in order for the patients to be eligible; patients with lobular carcinoma in-situ involving the resection margins are eligible
* Criteria re: other prior treatments:

* No prior chemotherapy for this malignancy
* No prior radiation therapy for this malignancy; this includes no prior MammoSite Brachytherapy radiation therapy (RT)
* Hormonal therapy: Patients who develop breast cancer while receiving a selective estrogen-receptor modulator (SERM; e.g., tamoxifen, toremifene, raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for breast cancer prevention or a SERM for other indications (e.g., raloxifene for osteoporosis) are not eligible; however, patients may have received up to 8 weeks of a SERM or aromatase inhibitor for this malignancy and still be eligible for study entry
* Patients must have an anticipated life expectancy of at least 10 years
* Patients with the following medical conditions should not be enrolled on the study:

* Chronic obstructive pulmonary disease requiring treatment
* Chronic liver disease (e.g., cirrhosis, chronic active hepatitis)
* Previous history of a cerebrovascular accident
* History of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline (e.g., doxorubicin or epirubicin)
* Chronic psychiatric condition or other condition that would impair compliance with the treatment regimen
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to pre-registration to rule out pregnancy

* Women of childbearing potential must be strongly advised to utilize an accepted and effective form of non-hormonal contraception (e.g. intrauterine device, condoms, diaphragm, abstinence)
* Patients must not have previously had the Oncotype DX Assay performed, with the exception of patients who have had the assay performed and have a recurrence score of 11-25
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2030
Actual
Sample size
Target
Accrual to date
Final
10273
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus-North Coast Cancer Institute - Coffs Harbour
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [5] 0 0
Lingard Private Hospital - Merewether
Recruitment hospital [6] 0 0
Royal Newcastle Hospital - New Castle
Recruitment hospital [7] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [9] 0 0
Nambour Hospital - Nambour
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Saint Hobart
Recruitment hospital [11] 0 0
Breast Unit-Mercy Private - East Melbourne
Recruitment hospital [12] 0 0
Epworth Hospital - Richmond
Recruitment hospital [13] 0 0
Saint John of God Hospital - Bunbury - Bunbury
Recruitment hospital [14] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2191 - Merewether
Recruitment postcode(s) [6] 0 0
2300 - New Castle
Recruitment postcode(s) [7] 0 0
2310 - Waratah
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4560 - Nambour
Recruitment postcode(s) [10] 0 0
7000 - Saint Hobart
Recruitment postcode(s) [11] 0 0
3002 - East Melbourne
Recruitment postcode(s) [12] 0 0
3121 - Richmond
Recruitment postcode(s) [13] 0 0
6230 - Bunbury
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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United States of America
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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Oregon
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Pennsylvania
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Wisconsin
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Wyoming
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
Country [58] 0 0
Canada
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Saskatchewan
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Ireland
State/province [59] 0 0
Co Cork
Country [60] 0 0
Ireland
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Co Dublin
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Ireland
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Co Galway
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Ireland
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Co Limerick
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Ireland
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Co Sligo
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Ireland
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Co Waterford
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Ireland
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Cork
Country [66] 0 0
Ireland
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Dublin
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Ireland
State/province [67] 0 0
Letterkenny
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New Zealand
State/province [68] 0 0
Auckland
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New Zealand
State/province [69] 0 0
Hamilton
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New Zealand
State/province [70] 0 0
Wellington
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Peru
State/province [71] 0 0
Lima
Country [72] 0 0
Puerto Rico
State/province [72] 0 0
San Juan
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Northern Ireland

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American College of Surgeons
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer and Leukemia Group B
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
NSABP Foundation Inc
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
NCIC Clinical Trials Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
North Central Cancer Treatment Group
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
SWOG Cancer Research Network
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT00310180
Trial related presentations / publications
Sadigh G, Gray RJ, Sparano JA, Yanez B, Garcia SF, Timsina LR, Obeng-Gyasi S, Gareen I, Sledge GW, Whelan TJ, Cella D, Wagner LI, Carlos RC. Assessment of Racial Disparity in Survival Outcomes for Early Hormone Receptor-Positive Breast Cancer After Adjusting for Insurance Status and Neighborhood Deprivation: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):579-586. doi: 10.1001/jamaoncol.2021.7656.
Yanez B, Gray RJ, Sparano JA, Carlos RC, Sadigh G, Garcia SF, Gareen IF, Whelan TJ, Sledge GW, Cella D, Wagner LI. Association of Modifiable Risk Factors With Early Discontinuation of Adjuvant Endocrine Therapy: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Oncol. 2021 Jun 17;7(8):1-7. doi: 10.1001/jamaoncol.2021.1693. Online ahead of print.
Lynch SM, Russell NM, Barron S, Wang CA, Loughman T, Dynoodt P, Fender B, Lopez-Ruiz C, O'Grady A, Sheehan KM, Fay J, Amberger-Murphy V, Saha A, Klinger R, Gonzalez CA, Al-Attar N, Rahman A, O'Leary D, Lanigan FT, Bracken AP, Crown J, Kelly CM, O'Connor DP, Gallagher WM. Prognostic value of the 6-gene OncoMasTR test in hormone receptor-positive HER2-negative early-stage breast cancer: Comparative analysis with standard clinicopathological factors. Eur J Cancer. 2021 Jul;152:78-89. doi: 10.1016/j.ejca.2021.04.016. Epub 2021 Jun 2.
Freidlin B, Hu C, Korn EL. Are restricted mean survival time methods especially useful for noninferiority trials? Clin Trials. 2021 Apr;18(2):188-196. doi: 10.1177/1740774520976576. Epub 2021 Feb 24.
Wagner LI, Gray RJ, Sparano JA, Whelan TJ, Garcia SF, Yanez B, Tevaarwerk AJ, Carlos RC, Albain KS, Olson JA Jr, Goetz MP, Pritchard KI, Hayes DF, Geyer CE, Dees EC, McCaskill-Stevens WJ, Minasian LM, Sledge GW Jr, Cella D. Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx. J Clin Oncol. 2020 Jun 10;38(17):1875-1886. doi: 10.1200/JCO.19.01866. Epub 2020 Apr 9.
Sparano JA, Gray RJ, Makower DF, Albain KS, Saphner TJ, Badve SS, Wagner LI, Kaklamani VG, Keane MM, Gomez HL, Reddy PS, Goggins TF, Mayer IA, Toppmeyer DL, Brufsky AM, Goetz MP, Berenberg JL, Mahalcioiu C, Desbiens C, Hayes DF, Dees EC, Geyer CE Jr, Olson JA Jr, Wood WC, Lively T, Paik S, Ellis MJ, Abrams J, Sledge GW Jr. Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):367-374. doi: 10.1001/jamaoncol.2019.4794.
Korn EL, Gray RJ, Freidlin B. Noninferiority trials with nonadherence to the assigned randomized treatment. Clin Trials. 2019 Dec;16(6):673-681. doi: 10.1177/1740774519868479. Epub 2019 Aug 14.
Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. N Engl J Med. 2019 Jun 20;380(25):2395-2405. doi: 10.1056/NEJMoa1904819. Epub 2019 Jun 3.
Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):111-121. doi: 10.1056/NEJMoa1804710. Epub 2018 Jun 3.
Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Perez EA, Olson JA Jr, Zujewski J, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin P, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg JL, Sledge GW. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2015 Nov 19;373(21):2005-14. doi: 10.1056/NEJMoa1510764. Epub 2015 Sep 27.
Public notes

Contacts
Principal investigator
Name 0 0
Joseph A Sparano
Address 0 0
ECOG-ACRIN Cancer Research Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00310180