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Biosimilar for breast cancer tracked in real-world study

NCT ID NCT07542496

Knowledge-focused Sponsor: Société Algérienne de Formation et Recherche en Oncologie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study is following 1,000 people with HER2-positive breast cancer who are receiving a pertuzumab biosimilar as part of their routine care. The goal is to see how doctors are using the drug and how well it works in both neoadjuvant (before surgery) and first-line metastatic settings. Researchers will track treatment patterns, response rates, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pertuzumab biosimilar
What this could lead to
If successful, this study could provide real-world evidence on how well a pertuzumab biosimilar works for breast cancer outside of controlled trials.
What could go wrong
This is an observational study, not a controlled experiment, so results may be influenced by patient selection and other factors. It does not test a new drug, only tracks existing use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 19 years at the time of inclusion; * Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH/CISH/SISH); * Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications; * Treatment prescribed as part of routine clinical care (outside of a clinical trial); * Patient informed and having provided written informed consent. Exclusion Criteria: * Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.); * Treatment administered as part of an interventional clinical trial; * History of severe allergy or known contraindication to pertuzumab; * Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer HER 2 positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CAC BLIDA, Algiers, Algeria 16000

    RECRUITING

    Algiers, Algeria

    Contact Email: •••••@•••••

  • CHU Béni Messous, Algiers, Algeria 16000

    RECRUITING

    Algiers, Algeria

    Contact Email: •••••@•••••

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