Participant flow

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) · Source last updated 2026-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   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. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO

   id

   FG000

   title

   Arm A

2. description

   Group 2 (Oncotype DX recurrence score 11-25): Patients 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. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO

   id

   FG001

   title

   Arm B

3. description

   Group 2 (Oncotype DX recurrence score 11-25): 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. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials

   id

   FG002

   title

   Arm C

4. description

   Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials

   id

   FG003

   title

   Arm D

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1629

      2. group Id

         FG001

         num Subjects

         3458

      3. group Id

         FG002

         num Subjects

         3449

      4. group Id

         FG003

         num Subjects

         1737

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         172

      type

      No On-study Data

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         7

      type

      Ineligible

   4. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         55

      3. group Id

         FG002

         num Subjects

         131

      4. group Id

         FG003

         num Subjects

         245

      type

      No Follow-up Data

   5. achievements

      1. group Id

         FG000

         num Subjects

         1619

      2. group Id

         FG001

         num Subjects

         3399

      3. group Id

         FG002

         num Subjects

         3312

      4. group Id

         FG003

         num Subjects

         1389

      comment

      Patients analyzed in the main analysis

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         59

      3. group Id

         FG002

         num Subjects

         137

      4. group Id

         FG003

         num Subjects

         348

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients needed to be preregistered to the trial for ONCOTYPE recurrence score test, patients then were assigned or randomized to one of the four arms based on the recurrence score.

recruitment Details

This study was activated on April 7, 2006 and closed to registrations on October 6, 2010. A total of 11,232 patients were preregistered for Recurrence Score evaluation and 10,273 proceeded to register on the study.

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Preserved source evidence · Not medical advice