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NCT01272037 · FLOW

Participant flow

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer · Source last updated 2026-08-28

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

groups
  1. description
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Chemo and Endocrine Therapy
  2. description
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Endocrine Therapy Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        28
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        175
      2. group Id
        FG001
        num Subjects
        93
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        111
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        41
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        19
      type
      Delinquent data
    7. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        29
      type
      Reason under review
    8. reasons
      1. group Id
        FG000
        num Subjects
        626
      2. group Id
        FG001
        num Subjects
        632
      type
      On treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2511
      2. group Id
        FG001
        num Subjects
        2507
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1504
      2. group Id
        FG001
        num Subjects
        1547
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1007
      2. group Id
        FG001
        num Subjects
        960
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
9383 participants were screened and 5083 were randomized to the trial: 2547 to the Chemo and Endocrine Therapy arm and 2536 to the Endocrine Therapy Alone arm. In the Chemo and Endocrine Therapy Arm, 36 were ineligible. In the Endocrine Therapy Alone arm, 29 were ineligible. Ultimately, 5018 participants were eligible in the participant flow: 2511 in the Chemo and Endocrine Therapy arm and 2507 in the Endocrine Therapy Alone arm.
Complete source fields
groups
  1. description
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Chemo and Endocrine Therapy
  2. description
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Endocrine Therapy Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        28
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        175
      2. group Id
        FG001
        num Subjects
        93
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        111
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        41
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        19
      type
      Delinquent data
    7. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        29
      type
      Reason under review
    8. reasons
      1. group Id
        FG000
        num Subjects
        626
      2. group Id
        FG001
        num Subjects
        632
      type
      On treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2511
      2. group Id
        FG001
        num Subjects
        2507
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1504
      2. group Id
        FG001
        num Subjects
        1547
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1007
      2. group Id
        FG001
        num Subjects
        960
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
9383 participants were screened and 5083 were randomized to the trial: 2547 to the Chemo and Endocrine Therapy arm and 2536 to the Endocrine Therapy Alone arm. In the Chemo and Endocrine Therapy Arm, 36 were ineligible. In the Endocrine Therapy Alone arm, 29 were ineligible. Ultimately, 5018 participants were eligible in the participant flow: 2511 in the Chemo and Endocrine Therapy arm and 2507 in the Endocrine Therapy Alone arm.

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Preserved source evidence · Not medical advice