Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02445391 · FLOW

Participant flow

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy · Source last updated 2026-07-27

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

groups
  1. description
    Patients undergo observation, and receive no active treatment.
    id
    FG000
    title
    Arm A (Observation) (Closed to Accrual 05/16/2016)
  2. description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    FG001
    title
    Arm B (Cisplatin or Carboplatin)
  3. description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    FG002
    title
    Arm C (Capecitabine) (Open to Accrual 6/22/2016)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      No active protocol treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Alternative therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        22
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Complicating disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Financial issue
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        16
      type
      Still on treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      Not start protocol therapy
    milestones
    1. achievements
      1. comment
        Patients on arm A were under observation, and there was no specified active protocol therapy.
        group Id
        FG000
        num Subjects
        3
      2. comment
        2 patients were assigned to arm B before 6/22/2106 (activation date of amendment #3), 197 patients were assigned to arm B after 6/22/2016. Arm A was permanently closed to accrual by 6/22/2016 and arm C was open to accrual after 6/22/2016.
        group Id
        FG001
        num Subjects
        199
      3. group Id
        FG002
        num Subjects
        213
      comment
      All patients who were randomized to one of the three arms in the trial throughout the accrual period between April 2015 and March 2021.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        197
      3. group Id
        FG002
        num Subjects
        213
      type
      Concurrently randomized to arms B and C
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Concurrently randomized to arms A and B
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        187
      3. group Id
        FG002
        num Subjects
        204
      type
      Started protocol therapy
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        185
      3. group Id
        FG002
        num Subjects
        199
      type
      Reported treatment data
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        186
      3. group Id
        FG002
        num Subjects
        201
      comment
      This is the analysis population for adverse event outcomes
      type
      Reported adverse event data
    7. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        199
      3. group Id
        FG002
        num Subjects
        213
      type
      Reported mortality data
    8. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. comment
        2 patients with basal-subtype disease were assigned to arm B before 6/22/2016; 148 patients with basal-subtype disease were assigned to arm B after 6/22/2016.
        group Id
        FG001
        num Subjects
        150
      3. group Id
        FG002
        num Subjects
        160
      type
      Basal-subtype disease
    9. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        148
      3. group Id
        FG002
        num Subjects
        160
      comment
      This is the primary analysis population for IDFS (primary endpoint) and OS and RFS (secondary endpoints).
      type
      Basal-subtype disease randomized after 6/22/2016
    10. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        46
      comment
      Intrinsic subtype was added as a stratification factor in amendment #3 (activated on 6/22/2016), all eligible patients regardless of intrinsic subtype were randomized to arms B and C
      type
      Non basal-subtype disease
    11. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      comment
      In amendment #7 (activated in Nov 2020), intrinsic subtype was removed as a stratification factor, all patients were randomized to arms B and C as long as they submitted tumor specimen for PAM50 test. Intrinsic subtype was not known at randomization. At the time of the final analysis, intrinsic subtype was still pending for these patients.
      type
      Intrinsic subtype unknown
    12. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        84
      type
      Reported health-related quality of life data at 6 months assessment
    title
    Overall Study
pre Assignment Details
Before randomization patients were tested about their intrinsic subtype using PAM50 assay at step 0. Before amendment #3, only basal subtype was eligible and was randomized. After amendment #3, all patients were eligible regardless of intrinsic subtype, and intrinsic subtype was added as a stratification factor. After amendment #7 (activated in November 2020), intrinsic subtype was no longer a stratification factor, patients were randomized as long as tumor specimen was submitted for PAM50 test.
recruitment Details
This study was activated on April 29, 2015, with the first accrual on October 20, 2015. Accrual was temporarily suspended on December 28, 2015. The study was reactivated on June 22, 2016 to continue enrollment of patients to arms B and C (capecitabine), and accrual to arm A was permanently closed. Patient accrual was closed on March 30, 2021 with final accrual of 560 patients to step 0 and 415 patients randomized to step 1. Only 415 patients enrolled at Step 1 are included in the analysis.
Complete source fields
groups
  1. description
    Patients undergo observation, and receive no active treatment.
    id
    FG000
    title
    Arm A (Observation) (Closed to Accrual 05/16/2016)
  2. description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    FG001
    title
    Arm B (Cisplatin or Carboplatin)
  3. description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    FG002
    title
    Arm C (Capecitabine) (Open to Accrual 6/22/2016)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      No active protocol treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Alternative therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        22
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Complicating disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Financial issue
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        16
      type
      Still on treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        9
      type
      Not start protocol therapy
    milestones
    1. achievements
      1. comment
        Patients on arm A were under observation, and there was no specified active protocol therapy.
        group Id
        FG000
        num Subjects
        3
      2. comment
        2 patients were assigned to arm B before 6/22/2106 (activation date of amendment #3), 197 patients were assigned to arm B after 6/22/2016. Arm A was permanently closed to accrual by 6/22/2016 and arm C was open to accrual after 6/22/2016.
        group Id
        FG001
        num Subjects
        199
      3. group Id
        FG002
        num Subjects
        213
      comment
      All patients who were randomized to one of the three arms in the trial throughout the accrual period between April 2015 and March 2021.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        197
      3. group Id
        FG002
        num Subjects
        213
      type
      Concurrently randomized to arms B and C
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Concurrently randomized to arms A and B
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        187
      3. group Id
        FG002
        num Subjects
        204
      type
      Started protocol therapy
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        185
      3. group Id
        FG002
        num Subjects
        199
      type
      Reported treatment data
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        186
      3. group Id
        FG002
        num Subjects
        201
      comment
      This is the analysis population for adverse event outcomes
      type
      Reported adverse event data
    7. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        199
      3. group Id
        FG002
        num Subjects
        213
      type
      Reported mortality data
    8. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. comment
        2 patients with basal-subtype disease were assigned to arm B before 6/22/2016; 148 patients with basal-subtype disease were assigned to arm B after 6/22/2016.
        group Id
        FG001
        num Subjects
        150
      3. group Id
        FG002
        num Subjects
        160
      type
      Basal-subtype disease
    9. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        148
      3. group Id
        FG002
        num Subjects
        160
      comment
      This is the primary analysis population for IDFS (primary endpoint) and OS and RFS (secondary endpoints).
      type
      Basal-subtype disease randomized after 6/22/2016
    10. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        46
      comment
      Intrinsic subtype was added as a stratification factor in amendment #3 (activated on 6/22/2016), all eligible patients regardless of intrinsic subtype were randomized to arms B and C
      type
      Non basal-subtype disease
    11. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      comment
      In amendment #7 (activated in Nov 2020), intrinsic subtype was removed as a stratification factor, all patients were randomized to arms B and C as long as they submitted tumor specimen for PAM50 test. Intrinsic subtype was not known at randomization. At the time of the final analysis, intrinsic subtype was still pending for these patients.
      type
      Intrinsic subtype unknown
    12. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        84
      type
      Reported health-related quality of life data at 6 months assessment
    title
    Overall Study
pre Assignment Details
Before randomization patients were tested about their intrinsic subtype using PAM50 assay at step 0. Before amendment #3, only basal subtype was eligible and was randomized. After amendment #3, all patients were eligible regardless of intrinsic subtype, and intrinsic subtype was added as a stratification factor. After amendment #7 (activated in November 2020), intrinsic subtype was no longer a stratification factor, patients were randomized as long as tumor specimen was submitted for PAM50 test.
recruitment Details
This study was activated on April 29, 2015, with the first accrual on October 20, 2015. Accrual was temporarily suspended on December 28, 2015. The study was reactivated on June 22, 2016 to continue enrollment of patients to arms B and C (capecitabine), and accrual to arm A was permanently closed. Patient accrual was closed on March 30, 2021 with final accrual of 560 patients to step 0 and 415 patients randomized to step 1. Only 415 patients enrolled at Step 1 are included in the analysis.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice