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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Albumin-bound paclitaxel plus capecitabine; Drug: capecitabine

• Registration Number: NCT04780347
• Lead Sponsor: Fudan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin-bound paclitaxel plus capecitabine	Albumin-bound paclitaxel plus capecitabine	Albumin-bound paclitaxel combined with capecitabine
Capecitabine	capecitabine	Capecitabine

Primary Outcome Measures

Name	Time	Method
PFS	approximately 6 weeks	Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
ORR	approximately 6 weeks	Objective Response Rate
OS	Up to approximately 30 months	Overall Survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer center; 🇨🇳 Shanghai, China