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

Conditions

• Breast Adenocarcinoma
• Hormone Receptor Positive
• 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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Anastrozole — DRUG
  Given PO
• Exemestane — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Letrozole — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo radiation therapy or partial breast irradiation
• Tamoxifen Citrate — DRUG
  Given PO

Study Details

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.

Key Dates

First listed

Apr 3, 2006

Start date

Apr 7, 2006

Status verified

Mar 2026

Primary completion

Mar 2, 2018

Completion

Sep 30, 2030

Study Design

Enrollment

10,273 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

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 ]

Locations (1160)