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Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

Active Not RecruitingPhase 2

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

Interventions: Docetaxel, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* 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

Exclusion Criteria:

* Patients have received prior taxane or prior/concurrent platinum therapy
* Patients have pre-existing peripheral neuropathy
* Patients have a total bilirubin \> upper limit of normal (ULN)
* Patients have aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 1.5 times the ULN concomitant with alkaline phosphatase above 2.5 times the ULN

Locations (485)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Anchorage, Alaska, United States
Fairbanks, Alaska, United States
Kingman, Arizona, United States
Fort Smith, Arkansas, United States
Jonesboro, Arkansas, United States
Arroyo Grande, California, United States
Burbank, California, United States
Dublin, California, United States
Emeryville, California, United States
Emeryville, California, United States
Martinez, California, United States
Oakland, California, United States
Oakland, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Boulder, Colorado, United States
Boulder, Colorado, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
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