Trial Outcomes & Findings for Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy (NCT NCT02445391)

Last Updated: 2026-01-16

Results Overview

IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

415 participants

Primary outcome timeframe

No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Results posted on

2026-01-16

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Arm A (Observation) (Closed to Accrual 05/16/2016) Patients undergo observation, and receive no active treatment.	Arm B (Cisplatin or Carboplatin) 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) 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
Overall Study STARTED	3	199	213
Overall Study Concurrently randomized to arms B and C	0	197	213
Overall Study Concurrently randomized to arms A and B	3	2	0
Overall Study Started protocol therapy	0	187	204
Overall Study Reported treatment data	0	185	199
Overall Study Reported adverse event data	0	186	201
Overall Study Reported mortality data	3	199	213
Overall Study Basal-subtype disease	3	150	160
Overall Study Basal-subtype disease randomized after 6/22/2016	0	148	160
Overall Study Non basal-subtype disease	0	42	46
Overall Study Intrinsic subtype unknown	0	7	7
Overall Study Reported health-related quality of life data at 6 months assessment	0	69	84
Overall Study Reported health-related quality of life data at 15 months assessment	0	37	54
Overall Study COMPLETED	0	146	141
Overall Study NOT COMPLETED	3	53	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Observation) (Closed to Accrual 05/16/2016) Patients undergo observation, and receive no active treatment.	Arm B (Cisplatin or Carboplatin) 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) 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
Overall Study No active protocol treatment	3	0	0
Overall Study Adverse Event	0	21	12
Overall Study Alternative therapy	0	0	1
Overall Study Disease progression	0	7	22
Overall Study Complicating disease	0	2	1
Overall Study Withdrawal by Subject	0	4	9
Overall Study Financial issue	0	0	2
Overall Study Still on treatment	0	7	16
Overall Study Not start protocol therapy	0	12	9

Baseline Characteristics

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm B (Cisplatin or Carboplatin) n=148 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=160 Participants 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	Total n=308 Participants Total of all reporting groups
Age, Continuous	52 years n=9 Participants	52 years n=6 Participants	52 years n=9 Participants
Sex: Female, Male Female	148 Participants n=9 Participants	160 Participants n=6 Participants	308 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=9 Participants	15 Participants n=6 Participants	33 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=9 Participants	136 Participants n=6 Participants	259 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=9 Participants	9 Participants n=6 Participants	16 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants	7 Participants n=6 Participants	10 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	28 Participants n=9 Participants	31 Participants n=6 Participants	59 Participants n=9 Participants
Race (NIH/OMB) White	104 Participants n=9 Participants	115 Participants n=6 Participants	219 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=9 Participants	7 Participants n=6 Participants	20 Participants n=9 Participants

PRIMARY outcome

Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=148 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=160 Participants 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
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients	42.0 percentage of participants Interval 30.5 to 53.1	49.4 percentage of participants Interval 39.0 to 59.0

SECONDARY outcome

Population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS rate was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=148 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=160 Participants 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
3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients	46.2 percentage of participants Interval 34.7 to 57.0	49.3 percentage of participants Interval 38.9 to 58.9

SECONDARY outcome

Timeframe: Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years

Population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=148 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=160 Participants 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
3-year Overall Survival (OS) Rate in Basal-Subtype Patients	57.8 percentage of participants Interval 45.2 to 68.4	66.2 percentage of participants Interval 56.3 to 74.3

SECONDARY outcome

Timeframe: Assessed at registration to step 0 (baseline)

Population: Analysis population was all patients who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results. Before 6/22/2016, only basal subtype was randomized to arms A and B. After 6/22/2016, all eligible patients were randomized to arms B and C regardless of their intrinsic subtype. Proportion of basal subtype was calculated in the 396 patients who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype assay results at the final analysis time.

Proportion of basal subtype was calculated as number of patients who had basal subtype disease divided by all triple-negative breast cancers who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results.

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=396 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) 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
Proportion of Basal Subtype	78 percentage of participants Interval 73.0 to 82.0	—

SECONDARY outcome

Timeframe: Assessed at 6 months after randomization

Population: All patients randomized to arms B and C and reported health-related quality of life data at 6-month assessment

HRQL was measured by the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI) Treatment Side Effects (TSE) subscale score, an aggregate score of 4 items (GP2, GP5, N6 and B5) from the FBSI-16 scale. The FBSI TSE subscale score was calculated based on the scoring manual, score ranges from 0 to 16, higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=69 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=84 Participants 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
Health-related Quality of Life (HRQL) at 6-month Assessment	14.7 score on a scale Standard Deviation 1.8	14.6 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Assessed at 15 months after randomization

Population: All patients randomized to arms B and C and reported health-related quality of life data at 15-month assessment

Outcome measures

Outcome measures
Measure	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) n=37 Participants 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	Arm C (Capecitabine) (Open to Accrual 6/22/2016) n=54 Participants 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
Health-related Quality of Life (HRQL) at 15-month Assessment	14.5 score on a scale Standard Deviation 2.3	14.9 score on a scale Standard Deviation 1.8

Adverse Events

Arm A (Observation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Arm B (Cisplatin or Carboplatin)

Serious events: 50 serious events

Other events: 141 other events

Deaths: 51 deaths

Arm C (Capecitabine)

Serious events: 32 serious events

Other events: 165 other events

Deaths: 45 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A (Observation) Patients were on observation and did not receive any treatment.	Arm B (Cisplatin or Carboplatin) n=186 participants at risk 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	Arm C (Capecitabine) n=201 participants at risk 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
Blood and lymphatic system disorders Anemia	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	54.8% 102/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	29.9% 60/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Skin and subcutaneous tissue disorders Alopecia	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	4.3% 8/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	5.5% 11/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	0.00% 0/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	56.2% 113/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Gastrointestinal disorders Constipation	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	18.8% 35/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	10.9% 22/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Gastrointestinal disorders Diarrhea	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	6.5% 12/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	44.8% 90/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Gastrointestinal disorders Nausea	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	46.2% 86/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	39.8% 80/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Gastrointestinal disorders Vomiting	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	15.1% 28/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	11.9% 24/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Investigations White blood cell decreased	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	56.5% 105/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	24.9% 50/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Nervous system disorders Peripheral sensory neuropathy	— 0/0 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	25.3% 47/186 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.	27.4% 55/201 • Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization. Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 16176323012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60