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

A Phase II, Single-center, Randomized Study of Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Albumin-bound paclitaxel plus capecitabine; Drug: capecitabine

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Jian Zhang, MD,PhD; Phone Number: +8618121299359; Email: syner2000@163.com
    • Contact: Yiqun Du, MD,PhD; Phone Number: +8618121299359; Email: dyqlh2010@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Drug: capecitabine; capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	approximately 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	approximately 6 weeks
OS	Overall Survival	Up to approximately 30 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): February 25, 2023

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; Albumin-bound paclitaxel; paclitaxel/docetaxel-resistant
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Capecitabine; Albumin-Bound Paclitaxel
• Other Study ID Numbers: YBCSG-21-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No