Page 11 - Delaware Medical Journal - July/August 2020

EAZ171: Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women
The objectives of the trial are:
Primary Endpoint:
• Prospectively validate a prior germline predictor of paclitaxel-induced peripheral neuropathy (TIPN) using the 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 Endpoints:
• Validate a prior germline predictor of TIPN using the FACT/GOG-NTX neurotoxicity subscale in Arm A.
• Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel (Arm A) vs. every three-week docetaxel (Arm B).
• 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.
• 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.
• Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel.
Correlative Study Objectives
Patient-Reported Outcome Objectives
Eligibility: Registration Step 1
• Patients must be age ≥ 18 years, not pregnant or lactating. ECOG Performance status 0-1.
• Patients must be women with a known stage I-III invasive breast cancer diagnosis. Registration must occur within 84 days from the date of diagnosis.
• Patients must have plans to receive either neoadjuvant or adjuvant:
Every 3-week docetaxel x 4-6 cycles OR Weekly paclitaxel x 4 cycles
• Patients must self-identify their race as black, African American, or of African descent. Patients may be of any ethnicity.
• Patients must not have received prior taxane or prior/concurrent platinum therapy.
• Patients must not have received neoadjuvant anti-HER2 therapy.
• Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy.
• Patients must not have pre-existing peripheral neuropathy.
• Patients must not have a total bilirubin > ULN or AST and/or ALT above 1.5 times the ULN concomitant with alkaline phosphatase above 2.5 times the ULN.
• Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study.
Treatment: Physician and Patient CHOICE
Arm 1: Lenalidomide x 2 years
Arm 2: Lenalidomide + Daratumumab/rHuPH20 x 2 years
2-YEAR MRD ASSESSMENT
MRD Negative: Step 3; Second Randomization
Arm A: Paclitaxel 80 mg/m2 every 7 days (weekly) for 4 cycles (1 cycle = 21 days). Arm B: Docetaxel 75 mg/m2 every 3 weeks (1 cycle = 21 days).
SEE PROTOCOL FOR FURTHER CLARIFICATION OF TREATMENT.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | July/August 2020 | Vol. 92 | No. 4 155