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NCT Number: NCT07166185

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

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.

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Key information

Conditions

Non Metastatic HER2 Positive Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Disease Progression Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical oncology department - Anti Cancer Center of Blida

Blida, 09000, Algeria

Location status: Recruiting

Location contact

Adda Bounedjar, PhD

CONTACT

[email protected]

+213 661651010

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pathological Complete Response (pCR) Rate

    Time frame: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.

    The proportion of participants with no residual invasive cancer in the breast and axillary lymph nodes after completion of neoadjuvant therapy, defined as ypT0/Tis ypN0 according to standard pathological assessment.

    Pathological evaluation will be performed on surgical specimens by certified pathologists following local and international guidelines.

Secondary outcomes

  1. Breast-Conserving Surgery Rate

    Time frame: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.

    Proportion of participants undergoing breast-conserving surgery after completion of neoadjuvant therapy. Determined from surgical records.

  2. Incidence of Adverse Events

    Time frame: From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks).

    Frequency and severity of treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version in use at study initiation.

  3. Patient Satisfaction With Treatment

    Time frame: Post-surgery (approximately 24-28 weeks after treatment initiation).

    Proportion of participants reporting satisfaction with subcutaneous administration of trastuzumab-pertuzumab (Phesgo), as assessed by a study-specific satisfaction questionnaire.

  4. Predictive Factors of Response

    Time frame: From baseline to surgery (approximately 18-24 weeks after treatment initiation).

    Association between clinical, pathological, and biological characteristics (including biomarkers) and pathological complete response.

Sponsors and collaborators

Lead sponsor

Blida 1 University

Other

Registry information

Official study title

Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women

Acronym: NEOTRAPSCAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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