Trial · NCT04001829
Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
NCT04001829, Phase 2, Active not recruiting, ECOG-ACRIN Cancer Research Group; results first posted 2024-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer. Trials, record NCT04001829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04001829
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
- NCT number
- NCT04001829
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 249 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
- Interventions
- Docetaxel, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2019-06-28
- Last updated
- 2026-10-06
- Results first posted
- 2024-06-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A | assessed at baseline, an end of each cycle, at 6 months and 1 year post registration | Grade 2-4 TIPN was assessed by treating physician using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All patients who started protocol therapy on arm A (paclitaxel) were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between high-risk vs low-risk genotype groups using Fisher exact test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status. |
| Secondary | Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A | assessed at baseline and at end of treatment, an average of 3 months | The patient-reported neurotoxicity was assessed using the 11 items about neurotoxicity in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx) questionnaire (i.e., FACT/GOG-Ntx additional concerns subscale). The neurotoxicity total score was the sum of the scores for the 11 items, ranging from 0 to 44. Higher values of the FACT/GOG-Ntx neurotoxicity total score indicate less neurotoxicity. The FACT/GOG-Ntx neurotoxicity total score change between the baseline and at end of treatment (negative value indicates worsening symptom, positive value indicates improving symptom) was calculated and compared using two-sample t test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status. |
| Secondary | Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B | assessed at baseline, an end of each cycle, at 6 months and 1 year post registration | Grade 2-4 TIPN was assessed by treating physician using CTCAE version 4.0. All patients who started protocol therapy were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between treatment arms using Fisher exact test. |
| Secondary | Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B | Dose reduction due to TIPN was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B | The percentage of patients with dose reduction due to TIPN was calculated as number of patients with dose reduction due to peripheral neuropathy for any dose of any cycle divided by total number of patients who started protocol therapy. The percentages were calculated along with exact 95% CI based on binomial distribution and were compared between arms using Fisher exact test. |
| Secondary | Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B | Dose reduction due to any reason was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B | The percentage of patients with dose reduction due to any reason was calculated as number of patients with any dose reduction for any dose of any cycle, regardless of the reason, divided by total number of patients who started protocol therapy. The percentages were calculated along with exact 95% CI based on binomial distribution and were compared between arms using Fisher exact test. |
| Secondary | Percentage of Participants With Grade 2-4 TIPN by Genotype Risk Group in Arm B | assessed at baseline, at end of each cycle, at 6 months and 1 year post registration | Grade 2-4 TIPN was assessed by treating physician using CTCAE version 4.0. All patients who started protocol therapy on arm B were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between high-risk vs low-risk genotype groups using Fisher exact test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A | assessed at baseline, an end of each cycle, at 6 months and 1 year post registration | All patients on arm A who received at least one dose of paclitaxel and had genotyping results | percentage of participants | NUMBER |
| SECONDARY | Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A | assessed at baseline and at end of treatment, an average of 3 months | All patients who started paclitaxel and filled out the FACT/GOG-Ntx questionnaire at both baseline and end of treatment time points | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B | assessed at baseline, an end of each cycle, at 6 months and 1 year post registration | All patients who received at least one dose of protocol therapy | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B | Dose reduction due to TIPN was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B | All patients who received at least one dose of protocol therapy | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B | Dose reduction due to any reason was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B | All patients who received at least one dose of protocol therapy | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 2-4 TIPN by Genotype Risk Group in Arm B | assessed at baseline, at end of each cycle, at 6 months and 1 year post registration | All patients who received at least one dose of docetaxel and had genotyping results | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A | High Risk Genotype Group | 47 | 90% Confidence Interval 38 to 56 | percentage of participants | |
| Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A | Low Risk Genotype Group | 35 | 90% Confidence Interval 19 to 53 | percentage of participants | |
| Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A | High Risk Genotype Group | -7.3 | Standard Deviation 9.1 | score on a scale | |
| Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A | Low Risk Genotype Group | -8.1 | Standard Deviation 8.9 | score on a scale | |
| Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B | Arm A (Paclitaxel) | 44 | 90% Confidence Interval 36 to 52 | percentage of participants | |
| Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B | Arm B (Docetaxel) | 25 | 90% Confidence Interval 19 to 33 | percentage of participants | |
| Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B | Arm A (Paclitaxel) | 28 | 95% Confidence Interval 20 to 37 | percentage of participants | |
| Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B | Arm B (Docetaxel) | 8 | 95% Confidence Interval 4 to 15 | percentage of participants | |
| Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B | Arm A (Paclitaxel) | 39 | 95% Confidence Interval 30 to 48 | percentage of participants | |
| Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B | Arm B (Docetaxel) | 25 | 95% Confidence Interval 17 to 33 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Paclitaxel) | 126 | |
| Overall Study | STARTED | Arm B (Docetaxel) | 123 | |
| Overall Study | Received protocol therapy | Arm A (Paclitaxel) | 121 | |
| Overall Study | Received protocol therapy | Arm B (Docetaxel) | 118 | |
| Overall Study | High Risk Genotype Group | Arm A (Paclitaxel) | 91 | |
| Overall Study | High Risk Genotype Group | Arm B (Docetaxel) | 87 | |
| Overall Study | Low Risk Genotype Group | Arm A (Paclitaxel) | 26 | |
| Overall Study | Low Risk Genotype Group | Arm B (Docetaxel) | 31 | |
| Overall Study | COMPLETED | Arm A (Paclitaxel) | 102 | |
| Overall Study | COMPLETED | Arm B (Docetaxel) | 102 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events354
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Paclitaxel) | 70 | 121 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Docetaxel) | 71 | 118 | |
| other | Edema limbs | General disorders and administration site conditions | Arm A (Paclitaxel) | 8 | 121 | |
| other | Edema limbs | General disorders and administration site conditions | Arm B (Docetaxel) | 18 | 118 | |
| other | Fatigue | General disorders and administration site conditions | Arm A (Paclitaxel) | 64 | 121 | |
| other | Fatigue | General disorders and administration site conditions | Arm B (Docetaxel) | 75 | 118 | |
| other | Pain | General disorders and administration site conditions | Arm A (Paclitaxel) | 24 | 121 | |
| other | Pain | General disorders and administration site conditions | Arm B (Docetaxel) | 18 | 118 | |
| other | General disorders and administration site conditions - Other | General disorders and administration site conditions | Arm A (Paclitaxel) | 6 | 121 | |
| other | General disorders and administration site conditions - Other | General disorders and administration site conditions | Arm B (Docetaxel) | 8 | 118 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Paclitaxel) | 7 | 126 |
| Total, all-cause mortality | Arm B (Docetaxel) | 6 | 123 |
| Total, other adverse events | Arm A (Paclitaxel) | 121 | 121 |
| Total, other adverse events | Arm B (Docetaxel) | 113 | 118 |
| Total, serious adverse events | Arm A (Paclitaxel) | 46 | 121 |
| Total, serious adverse events | Arm B (Docetaxel) | 61 | 118 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38828938 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1CA189828 | ECOG-ACRIN NCORP Research Base | WAGNER, LYNNE I.; ODWYER, PETER J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Paclitaxel) vs Arm B (Docetaxel): deaths from any cause | Trial comparisons |
| Arm A (Paclitaxel) vs Arm B (Docetaxel): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04001829
GET https://conductscience.org/api/trials/v1/NCT04001829/events?page=2