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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03939481
Other study ID # S1714
Secondary ID NCI-2018-01568S1
Status Active, not recruiting
Phase
First received
Last updated
Start date May 14, 2019
Est. completion date February 28, 2026

Study information

Verified date June 2024
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.


Description:

PRIMARY OBJECTIVES: I. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens. SECONDARY OBJECTIVES: I. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population. II. To assess the incidence of CIPN within one year in this patient population. III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population. OTHER OBJECTIVES: I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN. OUTLINE: Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1336
Est. completion date February 28, 2026
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage IV disease are not eligible. - Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after registration. (Note that docetaxel or paclitaxel may be administered with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.) - Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study. - Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.) - Patients who can complete Patient-Reported Outcome (PRO) instruments in English or Spanish must: - Agree to complete PROs at all scheduled assessments - Complete the baseline PRO forms prior to registration - Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson?s disease. - Patients must agree to submit required specimens for defined translational medicine. - Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient?s consent, specimens must be submitted. - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. - As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Study Design


Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Ovarian Epithelial
  • Lung Neoplasms
  • Lung Non-Small Cell Carcinoma
  • Ovarian Neoplasms
  • Peripheral Nervous System Diseases
  • 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
  • Stage I Lung Cancer AJCC v8
  • Stage I Ovarian Cancer AJCC v8
  • Stage IA Ovarian Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IB Lung Cancer AJCC v8
  • Stage IB Ovarian Cancer AJCC v8
  • Stage IC Ovarian Cancer AJCC v8
  • Stage II Lung Cancer AJCC v8
  • Stage II Ovarian Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIA Ovarian Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage IIB Ovarian Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8

Intervention

Drug:
Chemotherapy
Given chemotherapy regimen
Other:
Functional Assessment
Functional and sensory clinician assessments
Questionnaire Administration
Patient and physician reported responses

Locations

Country Name City State
Chile Instituto Nacional del Cancer Independence
Colombia Instituto Nacional De Cancerologia Bogota
Mexico Instituto Nacional De Cancerologia de Mexico Mexico City Tlalpan
United States Hawaii Cancer Care - Savio 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Cleveland Clinic Akron General Akron Ohio
United States McFarland Clinic PC - Ames Ames Iowa
United States AnMed Health Cancer Center Anderson South Carolina
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Randolph Hospital Asheboro North Carolina
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Waldo County General Hospital Belfast Maine
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States University of Virginia Cancer Center Charlottesville Virginia
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Cookeville Regional Medical Center Cookeville Tennessee
United States Mercy Hospital Coon Rapids Minnesota
United States Greater Regional Medical Center Creston Iowa
United States Carle on Vermilion Danville Illinois
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Bayhealth Hospital Kent Campus Dover Delaware
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States University of Maryland Shore Medical Center at Easton Easton Maryland
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Little Company of Mary Hospital Evergreen Park Illinois
United States McLeod Regional Medical Center Florence South Carolina
United States Florida Gynecologic Oncology Fort Myers Florida
United States Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
United States Kaiser Permanente-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Cone Health Cancer Center Greensboro North Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States HaysMed University of Kansas Health System Hays Kansas
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States South Carolina Cancer Specialists PC Hilton Head Island South Carolina
United States Edward Hines Jr VA Hospital Hines Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Ballad Health Cancer Care - Kingsport Kingsport Tennessee
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Joseph Hospital East Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Joseph London London Kentucky
United States Texas Tech University Health Sciences Center-Lubbock Lubbock Texas
United States UMC Cancer Center / UMC Health System Lubbock Texas
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bayhealth Hospital Sussex Campus Milford Delaware
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Trinity Cancer Care Center Minot North Dakota
United States Trinity Medical Center Moline Illinois
United States Monticello Cancer Center Monticello Minnesota
United States Saint Joseph Hospital Nashua New Hampshire
United States CarolinaEast Medical Center New Bern North Carolina
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente-Oakland Oakland California
United States Olathe Health Cancer Center Olathe Kansas
United States Desert Regional Medical Center Palm Springs California
United States Sacred Heart Hospital Pensacola Florida
United States Phoenixville Hospital Phoenixville Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Jefferson Healthcare Port Townsend Washington
United States Kaiser Permanente Northwest Portland Oregon
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Penobscot Bay Medical Center Rockport Maine
United States Nash General Hospital Rocky Mount North Carolina
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Salina Regional Health Center Salina Kansas
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Essentia Health Sandstone Sandstone Minnesota
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Spartanburg Medical Center Spartanburg South Carolina
United States Mercy Hospital Springfield Springfield Missouri
United States Lakeview Hospital Stillwater Minnesota
United States NHRMC Radiation Oncology - Supply Supply North Carolina
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Kent Hospital Warwick Rhode Island
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Rice Memorial Hospital Willmar Minnesota
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Winchester Hospital Winchester Massachusetts
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Metro Health Hospital Wyoming Michigan

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Chile,  Colombia,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Development of peripheral neuropathy Will be measured as an absolute increase of >= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment as the taxane-based chemotherapy regimens in this study are expected to be completed within 8 to 18 weeks. The presence of CIPN will be captured at 52 weeks to evaluate the duration of neuropathy which is anticipated to wane after treatment discontinuation. Up to 24 weeks
Secondary CIPN symptoms Patients experiencing a treatment change attributed to CIPN symptoms Up to 52 weeks
Secondary Dose Changes Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan) Up to 52 weeks
Secondary Health-related Quality of Life Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning. Up to 52 weeks
Secondary Visual Analog Toxicity Score Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead). Up to 52 weeks
Secondary Patient Reported Symptom Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 [no burden at all] to 10 [a great burden]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 [no burden at all] to 10 [a great burden]), 2) to assess severity of side effects from cancer treatment (scale 0 [no side effects]) to 10 [side effects extremely severe and unbearable]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 [side effects not severe at all] to 10 [side effects extremely severe and unbearable]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 [no burden at all] to 10 [a great burden]). Up to 52 weeks
Secondary Leisure-time Exercise Habits Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI > 24) and insufficiently active (LSI < 23) categories. Up to 52 weeks
Secondary Patient-Reported Outcomes Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE [CTCAE Version 5.0]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days". Up to 52 weeks
Secondary National Cancer Institute-Common Terminology Criteria for Adverse Events The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range. Up to 52 weeks
Secondary Assess incidence of CIPN Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Up to 52 weeks
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