Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04665986
• Other study ID #: NHP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2020
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Female patients, 18 years = age = 80 years; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive breast cancer(early stage or locally advanced) HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)=55% measured by ECHO Signed informed consent form (ICF) Exclusion Criteria: Metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension =180/110); Unable or unwilling to swallow tablets.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Navelbine
Navelbine 25mg/m2 on day 1 and 8, every 3 weeks
• Docetaxel
Docetaxel 90mg/m2 on day 1, every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.	Through study completion, an average of 1 year
Secondary	DFS	Disease-free Survival	Following surgery until Year 3
Secondary	DDFS	Distance Disease-free Survival	Following surgery until Year 3
Secondary	ORR	Objective Response Rate	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months