Non Metastatic HER2 Positive Breast CancerNEOTRAPSCALNCT07166185
Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer
An observational study of Non Metastatic HER2 Positive Breast Cancer, run by Blida 1 University at 1 site in Algeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Non Metastatic HER2 Positive Breast Cancer
- How many people
- 70 participants
- Where
- 1 siteAlgeria
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients diagnosed with HER2-positive, non-metastatic breast cancer and eligible for neoadjuvant therapy according to local clinical practice in Algeria. Participants will be recruited from three oncology centers: Anti Cancer Center of Blida, public hospital of Aïn Defla, and public hospital of Médéa.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria1 site, 1 recruiting
- Recruiting
Medical oncology department - Anti Cancer Center of Blida
Blida, 09000
Adda Bounedjar, PhD, +213 661651010, a_bounedjar@univ-blida.dz
About this study
Official title: Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women
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.
Read more
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.
- Keywords
- HER2 positive, Breast cancer, non metastatic, Neoadjuvant therapy, Algerian women, Subcutaneous trastuzumab-pertuzumab, pathologic complete response
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
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.
Measured: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.
Secondary outcomes (4)
Breast-Conserving Surgery Rate
Proportion of participants undergoing breast-conserving surgery after completion of neoadjuvant therapy. Determined from surgical records.
Measured: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.
Incidence of Adverse Events
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.
Measured: From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks).
Patient Satisfaction With Treatment
Proportion of participants reporting satisfaction with subcutaneous administration of trastuzumab-pertuzumab (Phesgo), as assessed by a study-specific satisfaction questionnaire.
Measured: Post-surgery (approximately 24-28 weeks after treatment initiation).
Predictive Factors of Response
Association between clinical, pathological, and biological characteristics (including biomarkers) and pathological complete response.
Measured: From baseline to surgery (approximately 18-24 weeks after treatment initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Mar 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic HER2 Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blida 1 University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166185
- Sponsor's protocol ID
- LRC 01.002
- Acronym
- NEOTRAPSCAL
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No