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

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04780347
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 15, 2020
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Feb 25, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PFS [approximately 6 weeks]

   Progression Free Survival

Secondary Outcome Measures

1. ORR [approximately 6 weeks]

   Objective Response Rate

2. OS [Up to approximately 30 months]

   Overall Survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer center	Shanghai		China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jian Zhang,MD, Chief physician, Fudan University
• ClinicalTrials.gov Identifier: NCT04780347
• Other Study ID Numbers: YBCSG-21-03
• First Posted: Mar 3, 2021
• Last Update Posted: Mar 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jian Zhang,MD, Chief physician, Fudan University: Breast cancer; Albumin-bound paclitaxel; paclitaxel/docetaxel-resistant
• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Capecitabine; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Mar 3, 2021