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Trial record 1 of 1 for:    ECOG EAZ171
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Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

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ClinicalTrials.gov Identifier: NCT04001829
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.

Condition or disease Intervention/treatment Phase
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 Drug: Docetaxel Drug: Paclitaxel Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (paclitaxel)
Patients receive paclitaxel 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 and/or pertuzumab per institution routine care per treating physician's discretion.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm B (docetaxel)
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, and/or pertuzumab per institution routine care per treating physician's discretion.
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Validation of a prior germline predictor of paclitaxel-induced peripheral neuropathy (Arm A) [ Time Frame: Baseline ]
    Patients will be coded as having the event as long as grade 2-4 neuropathy based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 occurred at any time during the observation period. Patients without neuropathy or with maximum of grade 1 neuropathy during the whole observation period will be coded as having no event.


Secondary Outcome Measures :
  1. Grade 2-4 taxane-induced peripheral neuropathy (TIPN) [ Time Frame: Up to 3 years post-registration ]
    Will be based on CTCAE between both Arm A versus (vs.) Arm.

  2. Patient-related outcome (PRO)-based neurotoxicity [ Time Frame: Up to 3 years post-registration ]
    Will be assessed using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) questionnaire. The FACT/GOG-Ntx neurotoxicity total score will be analyzed as a continuous variable. Linear mixed effect models with random intercept (repeated measures within single patients with unstructured covariance matrices) will be fit to estimate the average difference in FACT/GOG-Ntx neurotoxicity total score between high versus (vs.) low risk genotype groups in the paclitaxel arm. Time and patient and disease characteristics will be included as covariates in the linear mixed effect model. Genotype group-by-time interaction will be tested to see whether the difference between the two genotype groups depends on time. For comparison between arm A and arm B, the FACT/GOG-Ntx neurotoxicity total score change between the baseline and at end of treatment will be compared using two sample t test.

  3. Health-related quality of life (HRQoL) between both arms [ Time Frame: Up to 3 years post-registration ]
    The HRQoL total score will be analyzed as a continuous variable and compared between low and high-risk genotypes groups of the paclitaxel arm, and between the paclitaxel arm and the docetaxel arm groups, using two-sample t tests. Multivariable linear mixed effect models will also be fit to evaluate the time trend of HRQoL and to estimate the average group difference in HRQoL after adjusting for other covariates. Group-by-time interaction will be tested to see whether the difference in HRQoL between groups depends on time.

  4. Physical function between both arms [ Time Frame: Up to 3 years post-registration ]
    Will be measured using the (PROMIS) Physical Function version (v)2.0 Short From 10a. The PROMIS Physical Function T score will be analyzed as a continuous variable, and it will be compared between the two treatment arms (A&B) and for the high risk vs. low risk genotypes (in arm A) using two-sample t tests

  5. Financial toxicity between both arms [ Time Frame: Up to 6 months post-registration ]
    Will be assessed using the Comprehensive Score for Financial Toxicity (COST) scores and compared using a two-sample t tests.

  6. PRO-CTCAE scores of numbness, tingling, and general pain between both arms [ Time Frame: Up to 3 years post-registration ]
    Will present PRO-CTCAE scores for each attribute (frequency, severity and/or interference) separately and compare PRO-CTCAE severity (coded 0-4) with CTCAE grades for the corresponding time period.


Other Outcome Measures:
  1. Association between Social economic determinants of health and treatment completion [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with treatment completion per protocol

  2. Social economic determinants of health and FACT-Ntx neurotoxicity scores [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with FACT-Ntx neurotoxicity scores

  3. Association between social determinants of health and FACT-Ntx HRQoL scores [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with FACT-Ntx HRQoL scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 must not have received prior taxane or prior/concurrent platinum 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must not have a total bilirubin > upper limit of normal (ULN)
  • Patients must not 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001829


  Show 83 Study Locations
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bryan P Schneider ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT04001829     History of Changes
Other Study ID Numbers: EAZ171
NCI-2019-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAZ171 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EAZ171 ( Other Identifier: DCP )
EAZ171 ( Other Identifier: CTEP )
UG1CA189828 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action