An observational study in Non Metastatic HER2 Positive Breast Cancer, sponsored by Blida 1 University. Recruiting at 1 site in Algeria. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Blida 1 University · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 70 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Blida 1 University as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study also gives Trastuzumab, Pertuzumab. No intervention listed here names it: that was found by reading the record.
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.
Time frame: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.
Breast-Conserving Surgery Rate
Proportion of participants undergoing breast-conserving surgery after completion of neoadjuvant therapy. Determined from surgical records.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to surgery (approximately 18-24 weeks after treatment initiation).
Started Mar 2025 (actual). Primary completion is estimated for Oct 2025, 7 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 7 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.