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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00310180




Registration number
NCT00310180
Ethics application status
Date submitted
29/03/2006
Date registered
3/04/2006
Date last updated
7/06/2024

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
State/province [10] 0 0
Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
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Hawaii
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United States of America
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Idaho
Country [14] 0 0
United States of America
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Illinois
Country [15] 0 0
United States of America
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Indiana
Country [16] 0 0
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Iowa
Country [17] 0 0
United States of America
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Kansas
Country [18] 0 0
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Kentucky
Country [19] 0 0
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Louisiana
Country [20] 0 0
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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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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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United States of America
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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United States of America
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Wyoming
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Canada
State/province [52] 0 0
Alberta
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Canada
State/province [53] 0 0
British Columbia
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Canada
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Manitoba
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Canada
State/province [55] 0 0
New Brunswick
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Canada
State/province [56] 0 0
Ontario
Country [57] 0 0
Canada
State/province [57] 0 0
Quebec
Country [58] 0 0
Canada
State/province [58] 0 0
Saskatchewan
Country [59] 0 0
Ireland
State/province [59] 0 0
Co Cork
Country [60] 0 0
Ireland
State/province [60] 0 0
Co Dublin
Country [61] 0 0
Ireland
State/province [61] 0 0
Co Galway
Country [62] 0 0
Ireland
State/province [62] 0 0
Co Limerick
Country [63] 0 0
Ireland
State/province [63] 0 0
Co Sligo
Country [64] 0 0
Ireland
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Co Waterford
Country [65] 0 0
Ireland
State/province [65] 0 0
Cork
Country [66] 0 0
Ireland
State/province [66] 0 0
Dublin
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Ireland
State/province [67] 0 0
Letterkenny
Country [68] 0 0
New Zealand
State/province [68] 0 0
Auckland
Country [69] 0 0
New Zealand
State/province [69] 0 0
Hamilton
Country [70] 0 0
New Zealand
State/province [70] 0 0
Wellington
Country [71] 0 0
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/ct2/show/NCT00310180
Trial related presentations / publications
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/ct2/show/NCT00310180