Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer

NCT ID: NCT07166185

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

Brief Summary

This study aims to find out how effective and well-tolerated the subcutaneous form of trastuzumab-pertuzumab (known as Phesgo) is when given before surgery (neoadjuvant treatment) to Algerian women with early stage, HER2-positive breast cancer.

The study will take place in three oncology centers in Algeria (Blida, Aïn Defla, Médéa) and include around 70 adult women diagnosed with non-metastatic HER2-positive breast cancer. Participants will receive Phesgo along with standard chemotherapy over about 18 weeks, followed by surgery.

The main goal is to measure how many women achieve complete destruction of invasive cancer in the breast and nearby lymph nodes (pathological complete response, pCR). We will also look at other outcomes such as how many women can keep their breast, any side effects, quality of life, satisfaction with treatment, and factors that might predict response.

Results from this real-world study will help assess whether Phesgo can simplify treatment delivery, reduce hospital burden, and improve care access in Algeria where healthcare resources are often stretched.

Conditions

Non Metastatic HER2 Positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Female participants aged 19 years or older.
• Histologically confirmed HER2-positive breast cancer (by immunohistochemistry and/or in situ hybridization), non-metastatic.
• Candidate for neoadjuvant therapy according to local clinical practice.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Left ventricular ejection fraction (LVEF) ≥ 50%.
• Signed written informed consent.

Exclusion Criteria

• Evidence of distant metastases.
• Prior anti-HER2 therapy.
• Known contraindications to trastuzumab or pertuzumab.
• Pregnancy or breastfeeding.
• Disease progression during neoadjuvant treatment (if already started).
• Refusal of surgery.
• Withdrawal of consent.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Blida 1 University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical oncology department - Anti Cancer Center of Blida

Blida, , Algeria

Site Status: RECRUITING

Countries

Algeria

Facility Contacts

Adda Bounedjar, PhD

Role: primary

a_bounedjar@univ-blida.dz

+213 661651010

Other Identifiers

LRC 01.002

Identifier Type: -

Identifier Source: org_study_id