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New precision approach aims to wipe out breast cancer before surgery

NCT ID NCT05582499

Disease control Sponsor: Fudan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial at Fudan University tests several targeted drug combinations given before surgery for early-stage breast cancer. The goal is to see which combinations best eliminate all signs of cancer (pathological complete response) based on each tumor's specific subtype. About 716 participants with operable breast cancer will receive tailored neoadjuvant therapy, with follow-up to assess long-term outcomes.

What this could mean

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

Active substance
Dalpiciclib, Pyrotinib, SHR-A1811, SHR-1316, Camrelizumab, SHR-A1921, Pertuzumab, Trastuzumab, Goserelin
What this could lead to
If successful, this could identify more effective drug combinations tailored to specific breast cancer subtypes, potentially increasing the chance of eliminating all cancer before surgery.
What could go wrong
This is a Phase 2 single-center trial, so results may not apply broadly. The many drug combinations increase complexity and risk of side effects, and not all may prove effective.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 716 people

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

Started

Nov 2022

Expected to finish

Sep 2029

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.

Ages

18 to 70 years

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: * Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0; * Age between18-70 years; * Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * ER, PR and HER2 status were measured by immunohistochemistry (IHC); * LVEF≥55%； * Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices; * Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping; * At least one measurable lesion according to RECIST version 1.1 * Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); * Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; * Ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; * Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II); * Patients with severe systemic infections or other serious diseases; * Patients with known allergy or intolerance to the study drug or its excipients; * Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; * Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study; * Participated in other trial studies within 30 days before the administration of the first dose of the study drug; * Patients who were judged by the investigator to be unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma Her2-receptor negative breast cancer hormone receptor-positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer Breast neoplasm Breast tumors Early-stage breast cancer HER2-negative breast cancer HER2-positive breast cancer Hormone receptor negative tumor Hormone receptor positive tumor Locally advanced breast cancer Triple negative breast cancer (TNBC)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Fudan University Shanghai Cancer Center Shanghai, China, 200032

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.