Precision neoadjuvant therapy for operable breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a platform for precision neoadjuvant therapy in patients with operable breast cancer, focusing on clinical subtypes. It will compare the efficacy of novel drugs, either alone or in combination with standard chemotherapy, against standard therapy alone. Eligible patients will be randomly assigned to either a precision treatment group or a conventional chemotherapy group based on their molecular typing. The trial will adapt over time, incorporating new findings from translational research to refine treatment regimens and identify effective biomarker signatures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center Shanghai, China, 200032
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhimin Shao, Professor — Fudan University
• Study coordinator: Zhimin Shao, Professor
• Email: zhimingshao@yahoo.com
• Phone: +86(021)64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized treatment for breast cancer using new drug agents

  This study is testing new drug combinations with standard chemotherapy to see which treatments work best for different types of breast cancer based on the specific characteristics of each patient's tumor.

  Recruiting at 32 sites Phase 2 QuantumLeap Healthcare Collaborative · Birmingham, Alabama and 41 other locations · NCT01042379

• Precision therapy for advanced breast cancer patients

  This study is testing different targeted treatments for patients with advanced breast cancer who have already tried certain medications, to see if personalized options can help them feel better.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT05594095

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• RGT-490 for adults with PIK3CA-mutated advanced solid tumors

  This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.

  Recruiting at 6 sites Phase 1 Regor Pharmaceuticals Inc. · Los Angeles, California and 5 other locations · NCT07524322

• RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant for PIK3CA‑mutant HR+/HER2‑ advanced breast cancer

  This trial tests whether RLY-2608 combined with fulvestrant works better than capivasertib combined with fulvestrant for adults with HR+/HER2‑ advanced breast cancer that has a PIK3CA mutation and progressed after a CDK4/6 inhibitor.

  Recruiting at 254 sites Phase 3 Relay Therapeutics, Inc. · Gilbert, Arizona and 253 other locations · NCT06982521

• Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy

  This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.

  Recruiting at 24 sites Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Aviano and 23 other locations · NCT06805812

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.