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

NCT04780347 | Unknown Phase 2

• 1 other identifier: YBCSG-21-03
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast cancer; Albumin-bound paclitaxel; paclitaxel/docetaxel-resistant

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  approximately 6 weeks

Secondary Outcomes (2)

• ORR

  approximately 6 weeks

• OS

  Up to approximately 30 months

Study Arms (2)

Albumin-bound paclitaxel plus capecitabine

EXPERIMENTAL

Albumin-bound paclitaxel combined with capecitabine

Drug: Albumin-bound paclitaxel plus capecitabine

Capecitabine

ACTIVE COMPARATOR

Capecitabine

Drug: capecitabine

Interventions

Albumin-bound paclitaxel plus capecitabine DRUG

Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w； capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.

Albumin-bound paclitaxel plus capecitabine

capecitabine DRUG

capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.

Capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with age between 18 and 70 years old
• Histological proven unresectable recurrent or advanced breast cancer
• 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.
• Patients who developed disease progression within 12 months of previous paclitaxel-containing chemotherapy regimens.
• At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
• Performance status no more than 1
• All patients enrolled are required to have adequate hematologic, hepatic, and renal function
• Life expectancy longer than 12 weeks
• No serious medical history of heart, lung, liver and kidney
• Be able to understand the study procedures and sign informed consent.
• Patients with good compliance.

You may not qualify if:

• 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)
• Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
• Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
• Treatment with an investigational product within 4 weeks before the first treatment
• 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
• 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.
• 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
• Uncontrolled serious infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: December 15, 2020
• Primary Completion: December 30, 2022
• Study Completion: February 25, 2023
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

CN (1)