Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04001829
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2019-06-19
Brief Title:
Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Prospective Validation Trial of Taxane Therapy Docetaxel or Weekly Paclitaxel and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies whether a prior germline predictor of taxane-induced peripheral neuropathy TIPN can help identify a subgroup of patients who are at higher risk of chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer The study also investigates whether docetaxel maybe work better than paclitaxel with regard to TIPN rateseverity and dose reductions
Detailed Description:
PRIMARY OBJECTIVES
I Prospectively validate a prior germline predictor of TIPN using the Common Terminology Criteria for Adverse Events CTCAE Specifically this study will demonstrate that patients with a high-risk TIPN genotype have significantly more grade 2-4 TIPN than patients with a low risk genotype
SECONDARY OBJECTIVES
I Validate a prior germline predictor of TIPN using the Functional Assessment of Cancer Therapy FACTGynecologic Oncology Group GOG-Neurotoxicity NTX neurotoxicity subscale in Arm A
II Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel Arm A versus vs every three-week docetaxel Arm B
III Prospectively confirm dose reductions due to TIPN are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry
IV Prospectively confirm dose reductions due to any cause are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry
V Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel
EXPLORATORY OBJECTIVES
Correlative Study Objectives
I Identify novel markers of TIPN and elucidate the mechanism II Whole genome sequencing of germline blood to evaluate for additional predictors of TIPN
III Create induced pluripotent stem cell iPSC derived neurons from patient samples
IIIa Evaluate whether clinical findings can be mimicked in vitro IIIb Evaluate gene expression ribonucleic acid RNA sequencing seq and the epigenome at baseline versus after exposure in those prone to TIPN versus those not
IV Create a biorepository of patient derived samples for future translational research
Patient-Reported Outcome Objectives
I Compare Grade 2-4 TIPN moderate to life threatening based on Patient Reported Outcomes PRO-CTCAE items between weekly paclitaxel Arm A vs every three-week docetaxel Arm B
II Prospectively compare FACTGOG-NTX Health-Related Quality of Life HRQoL subscale Patient-Reported Outcomes Measurement Information System PROMIS Physical Function version v2 Short Form SF 10a scores between every three-week docetaxel and weekly paclitaxel and between high risk and low risk genotypes Arm A in a cohort of African ancestry
III Compare the impact on financial toxicity Comprehensive Score for Financial Toxicity COST scores for every three-week docetaxel compared with weekly paclitaxel
IV Examine associations between social determinants of health zip code marital status education income insurance status and dose reductions and treatment discontinuation
OUTLINE Patients are assigned to 1 of 2 arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours once weekly Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity Patients may also receive trastuzumab andor pertuzumab per institution routine care per treating physicians discretion
ARM B Patients receive docetaxel IV over 1 hour once every 3 weeks Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity Patients may also receive cyclophosphamide doxorubicin trastuzumab andor pertuzumab per institution routine care per treating physicians discretion
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I Prospectively validate a prior germline predictor of TIPN using the Common Terminology Criteria for Adverse Events CTCAE Specifically this study will demonstrate that patients with a high-risk TIPN genotype have significantly more grade 2-4 TIPN than patients with a low risk genotype
SECONDARY OBJECTIVES
I Validate a prior germline predictor of TIPN using the Functional Assessment of Cancer Therapy FACTGynecologic Oncology Group GOG-Neurotoxicity NTX neurotoxicity subscale in Arm A
II Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel Arm A versus vs every three-week docetaxel Arm B
III Prospectively confirm dose reductions due to TIPN are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry
IV Prospectively confirm dose reductions due to any cause are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry
V Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel
EXPLORATORY OBJECTIVES
Correlative Study Objectives
I Identify novel markers of TIPN and elucidate the mechanism II Whole genome sequencing of germline blood to evaluate for additional predictors of TIPN
III Create induced pluripotent stem cell iPSC derived neurons from patient samples
IIIa Evaluate whether clinical findings can be mimicked in vitro IIIb Evaluate gene expression ribonucleic acid RNA sequencing seq and the epigenome at baseline versus after exposure in those prone to TIPN versus those not
IV Create a biorepository of patient derived samples for future translational research
Patient-Reported Outcome Objectives
I Compare Grade 2-4 TIPN moderate to life threatening based on Patient Reported Outcomes PRO-CTCAE items between weekly paclitaxel Arm A vs every three-week docetaxel Arm B
II Prospectively compare FACTGOG-NTX Health-Related Quality of Life HRQoL subscale Patient-Reported Outcomes Measurement Information System PROMIS Physical Function version v2 Short Form SF 10a scores between every three-week docetaxel and weekly paclitaxel and between high risk and low risk genotypes Arm A in a cohort of African ancestry
III Compare the impact on financial toxicity Comprehensive Score for Financial Toxicity COST scores for every three-week docetaxel compared with weekly paclitaxel
IV Examine associations between social determinants of health zip code marital status education income insurance status and dose reductions and treatment discontinuation
OUTLINE Patients are assigned to 1 of 2 arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours once weekly Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity Patients may also receive trastuzumab andor pertuzumab per institution routine care per treating physicians discretion
ARM B Patients receive docetaxel IV over 1 hour once every 3 weeks Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity Patients may also receive cyclophosphamide doxorubicin trastuzumab andor pertuzumab per institution routine care per treating physicians discretion
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-00266 | REGISTRY | None | None |
| EAZ171 | OTHER | None | None |
| ECOG-ACRIN-EAZ171 | OTHER | None | None |
| EAZ171 | OTHER | None | None |
| UG1CA189828 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189828 |