Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Bre… (NCT04001829) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
United States249 participantsStarted 2019-08-09
Plain-language 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 rate/severity and dose reductions.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 be capable and willing to provide informed consent
* Patients must have plans to receive either neoadjuvant or adjuvant:
* Every 3-week docetaxel x 4-6 cycles OR
* Weekly paclitaxel x 4 cycles
* NOTE: Recommended therapies for various therapy regimens are outlined based on estrogen receptor (ER)/progesterone receptor (PR)/HER2 and nodal status. Where there are options, the treating physician will choose a regimen best fitted for that patient. If the physician does not feel any of the regimens are the best fit for the patient, the patient should not be enrolled. Physicians will also document why a regimen was felt to be inappropriate when an option
* Patients must self-identify their race as black, African American, or of African descent; patients may be of any ethnicity
* Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must not be pregnant or lactating
* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who mee…
What they're measuring
1
Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A
Timeframe: assessed at baseline, an end of each cycle, at 6 months and 1 year post registration