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Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) (TAILORx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310180
Recruitment Status : Active, not recruiting
First Posted : April 3, 2006
Results First Posted : March 12, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
American College of Surgeons
Cancer and Leukemia Group B
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Adenocarcinoma Estrogen Receptor and/or Progesterone Receptor Positive HER2/Neu Negative Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIB Breast Cancer AJCC v7 Drug: Anastrozole Drug: Exemestane Other: Laboratory Biomarker Analysis Drug: Letrozole Other: Quality-of-Life Assessment Radiation: Radiation Therapy Drug: Tamoxifen Citrate Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
Actual Study Start Date : April 7, 2006
Actual Primary Completion Date : March 2, 2018
Estimated Study Completion Date : September 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
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.
Drug: Anastrozole
Given PO
Other Names:
  • Anastrazole
  • Arimidex
  • ICI D1033
  • ICI-D1033
  • ZD-1033

Drug: Exemestane
Given PO
Other Names:
  • Aromasin
  • FCE-24304

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Undergo radiation therapy or partial breast irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Drug: Tamoxifen Citrate
Given PO
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide

Experimental: Group 2, Arm I (experimental)
Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician.
Drug: Anastrozole
Given PO
Other Names:
  • Anastrazole
  • Arimidex
  • ICI D1033
  • ICI-D1033
  • ZD-1033

Drug: Exemestane
Given PO
Other Names:
  • Aromasin
  • FCE-24304

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Tamoxifen Citrate
Given PO
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide

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.
Drug: Anastrozole
Given PO
Other Names:
  • Anastrazole
  • Arimidex
  • ICI D1033
  • ICI-D1033
  • ZD-1033

Drug: Exemestane
Given PO
Other Names:
  • Aromasin
  • FCE-24304

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Undergo radiation therapy or partial breast irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Drug: Tamoxifen Citrate
Given PO
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide

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.
Drug: Anastrozole
Given PO
Other Names:
  • Anastrazole
  • Arimidex
  • ICI D1033
  • ICI-D1033
  • ZD-1033

Drug: Exemestane
Given PO
Other Names:
  • Aromasin
  • FCE-24304

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Undergo radiation therapy or partial breast irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Drug: Tamoxifen Citrate
Given PO
Other Names:
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Soltamox
  • TAM
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide




Primary Outcome Measures :
  1. 5-year Disease-free Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ]
    Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model.


Secondary Outcome Measures :
  1. 5-year Distant Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years ]
    Distant recurrence-free interval (DRFI) is defined as time from date of randomization or registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death is the first manifestation of distant recurrence. The distribution of DRFI (eg, 5-year DRFI rate) is estimated using Kaplan-Meier method.

  2. 5-year Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years ]
    Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method.

  3. 5-year Overall Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years ]
    Overall survival (OS) is defined as time from date of randomization or registration to date of death from any cause. The distribution of OS (eg, 5-year OS rate) is estimated using Kaplan-Meier method.

  4. 5-year Disease-free Survival by Age and Recurrence Score Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ]
    Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. >25) and age groups (<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method.

  5. To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test [ Time Frame: Assessed at 10 years after study entry ]
    Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.

  6. 5-year Disease-free Survival by Individual RS Gene Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years ]
    Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. 5-year DFS by individual RS gene groups (Proliferation Gene Group, HER2 Gene Group, ER Gene Group, Invasion Gene Group, and Other Genes) will be estimated in each arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310180


  Show 1219 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
American College of Surgeons
Cancer and Leukemia Group B
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Investigators
Layout table for investigator information
Principal Investigator: Joseph A Sparano ECOG-ACRIN Cancer Research Group
  Study Documents (Full-Text)

Documents provided by National Cancer Institute (NCI):

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310180     History of Changes
Obsolete Identifiers: NCT00554931
Other Study ID Numbers: NCI-2009-00707
NCI-2009-00707 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000472066
ECOG-PACCT-1
06-482
PACCT-1
PACCT-1 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
PACCT-1 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2006    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tamoxifen
Letrozole
Anastrozole
Exemestane
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents