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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B American College of Surgeons North Central Cancer Treatment Group National Cancer Institute of Canada National Surgical Adjuvant Breast and Bowel Project (NSABP) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310180 |
RATIONALE: 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 or by stopping them from dividing. 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.
PURPOSE: This randomized phase III trial is trying to find out 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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: chemotherapy Drug: exemestane Drug: letrozole Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial |
Estimated Enrollment: | 11248 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1 (Oncotype DX recurrence score < 11): Experimental
Patients in this group will receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane by mouth for up to 5 years. Some patients will then continue to receive hormone therapy for an additional 5 years.
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Drug: anastrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: exemestane
Given after chemotherapy or by mouth alone for up to 10 years
Drug: letrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: tamoxifen citrate
Given after chemotherapy or by mouth alone for up to 10 years
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Group 2 (Oncotype DX recurrence score 11-25): Experimental
Patients in this group will be randomly assigned to receive either hormone therapy alone or combination chemotherapy and hormone therapy.
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Drug: anastrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: chemotherapy
Given prior to hormone therapy in some patients
Drug: exemestane
Given after chemotherapy or by mouth alone for up to 10 years
Drug: letrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: tamoxifen citrate
Given after chemotherapy or by mouth alone for up to 10 years
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Group 2, arm I (experimental): Experimental
Patients receive hormonal therapy as in group 1 at the discretion of the treating physician.
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Drug: anastrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: exemestane
Given after chemotherapy or by mouth alone for up to 10 years
Drug: letrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: tamoxifen citrate
Given after chemotherapy or by mouth alone for up to 10 years
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Group 2, arm II (standard): Active Comparator
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.
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Drug: anastrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: chemotherapy
Given prior to hormone therapy in some patients
Drug: exemestane
Given after chemotherapy or by mouth alone for up to 10 years
Drug: letrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: tamoxifen citrate
Given after chemotherapy or by mouth alone for up to 10 years
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Group 3 (Oncotype DX recurrence score > 25): Experimental
Patients in this group will receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.
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Drug: anastrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: chemotherapy
Given prior to hormone therapy in some patients
Drug: exemestane
Given after chemotherapy or by mouth alone for up to 10 years
Drug: letrozole
Given after chemotherapy or by mouth alone for up to 10 years
Drug: tamoxifen citrate
Given after chemotherapy or by mouth alone for up to 10 years
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone surgery to remove the primary tumor by either a mastectomy or local excision plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy and/or axillary dissection) within the past 84 days
Must have adequate (i.e., ≥ 1 mm, if margin width specified) tumor-free margins of resection for invasive and ductal carcinoma in situ
Tumor size 1.1-5.0 cm
Pathologic tumor size should be used
Tissue specimen from the primary tumor available for diagnostic testing with Oncotype DX to determine Oncotype Recurrence Score
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Joseph A. Sparano, MD | Montefiore Medical Center |
Study Chair: | Daniel F. Hayes, MD | University of Michigan Cancer Center |
Study Chair: | Elizabeth C. Dees, MD | UNC Lineberger Comprehensive Cancer Center |
Study Chair: | John A. Olson, MD, PhD | Duke University |
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Study Chair: | Kathleen I. Pritchard, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study Chair: | Charles E. Geyer, FACP, MD | Allegheny Cancer Center at Allegheny General Hospital |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000472066, ECOG-PACCT-1, SWOG-ECOG-PACCT-1, CALGB-ECOG-PACCT-1, NCCTG-ECOG-PACCT-1, NSABP-ECOG-PACCT-1, ACOSOG-ECOG-PACCT-1, CAN-NCIC-MAC12 |
Study First Received: | March 29, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00310180 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIB breast cancer |
Estrogen Antagonists Anastrozole Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Bone Density Conservation Agents Letrozole Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Exemestane Aromatase Inhibitors Breast Diseases |
Estrogen Antagonists Anastrozole Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Breast Diseases |