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Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT04780347
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Jian Zhang,MD, Fudan University

Brief Summary:
Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Albumin-bound paclitaxel plus capecitabine Drug: capecitabine Phase 2

Detailed Description:
A Phase II, single-center, randomized study of albumin-bound paclitaxel combination with capecitabine versus capecitabine monotherapy in paclitaxel/docetaxel-resistant advanced breast cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-center, Randomized Study of Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : February 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Albumin-bound paclitaxel plus capecitabine
Albumin-bound paclitaxel combined with capecitabine
Drug: Albumin-bound paclitaxel plus capecitabine
Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w; capecitabine 1000 mg/m2, PO,bid, D1-14,q3w.

Active Comparator: Capecitabine
Capecitabine
Drug: capecitabine
capecitabine: capecitabine 1000 mg/m2, PO,bid, D1-14,q3w.




Primary Outcome Measures :
  1. PFS [ Time Frame: approximately 6 weeks ]
    Progression Free Survival


Secondary Outcome Measures :
  1. ORR [ Time Frame: approximately 6 weeks ]
    Objective Response Rate

  2. OS [ Time Frame: Up to approximately 30 months ]
    Overall Survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females with age between 18 and 70 years old
  2. Histological proven unresectable recurrent or advanced breast cancer
  3. Negative for human epithelial receptor-2 (HER2) by immunohistochemistry. A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
  4. Patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens.
  5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
  6. Performance status no more than 1
  7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
  8. Life expectancy longer than 12 weeks
  9. No serious medical history of heart, lung, liver and kidney
  10. Be able to understand the study procedures and sign informed consent.
  11. Patients with good compliance.

Exclusion Criteria:

  1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
  2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
  3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
  4. Treatment with an investigational product within 4 weeks before the first treatment
  5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
  6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
  7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
  8. Uncontrolled serious infection

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): NCT04780347


Locations
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China
Fudan University Shanghai Cancer center Recruiting
Shanghai, China, 200032
Contact: Jian Zhang, MD,PhD    +8618121299359    syner2000@163.com   
Contact: Yiqun Du, MD,PhD    +8618121299359    dyqlh2010@163.com   
Sponsors and Collaborators
Fudan University
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Responsible Party: Jian Zhang,MD, Chief physician, Fudan University
ClinicalTrials.gov Identifier: NCT04780347    
Other Study ID Numbers: YBCSG-21-03
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian Zhang,MD, Fudan University:
Breast cancer
Albumin-bound paclitaxel
paclitaxel/docetaxel-resistant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Capecitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites