PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

PLD Plus Cyclophosphamide Followed by Nab-paclitaxel (Nab-P) as Primary Chemotherapy Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer: A Single-arm Phase 2 Trial(Brecan Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346107
• Other study ID #: KY20223267-1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Xijing Hospital
• Contact: Nan lin li
• Phone: 02984775271
• Email: linanlingo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

patients with HER2-positive breast cancer (cT2-3/N0-1/M0) were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles

Description:

Upon approval by the Medical Ethics Committee of Xijing Hospital, patients with HER2-positive breast cancer (cT2-3/N0-1/M0) receiving neoadjuvant therapy, were enrolled. The patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity. The primary endpoint was pCR rate, and secondary endpoints were cardiac safety during neoadjuvant therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. HER2-positive breast cancer

2. cT2-3/N0-1/M0

3. aged18-80 years

4. receiving neoadjuvant therapy

5. ECOGPS score 0 or 1

6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures

7. Adequate organ function

Exclusion Criteria:

1. cardiac, hepatic, renal, or psychiatric disease history

2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage
The patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity.

Locations

Country	Name	City	State
China	Xijing Hospital , Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of pathological complete response	absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)	At the end of Cycle 1 (each cycle is 14 days)
Secondary	adverse effects	Serious adverse effect occur within neoadjuvant chemotherapy	during the period of neadjuvant chemotherapy, an average of 14 days