Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients

NCT04750122 | Recruiting Phase 1

• 1 other identifier: PekingUPH10B003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now. Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a metheod for omitting chemotherapy for her2 positive participants.

Conditions

HER2-positive Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response(pCR)

  ypT0/is, ypN0

  up to 12 weeks

Secondary Outcomes (3)

• event-free survival (EFS)

  5 years

• invasive disease-free survival(IDFS)

  5 years

• objective response rate

  up to 12 weeks

Study Arms (1)

Neoadjuvant therapy base on PTC drug screenning

EXPERIMENTAL

Patients will receive neoadjuvant therapy including trastuzumab, pertuzumab, and chemotherapy based on PTC drug screening.

Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning

Interventions

neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning DRUG

The choice of chemotherapy is based on the PTC drug sensitivity results.

Also known as: docetaxel and trastuzumab and pertuzumab, docetaxel and carboplatin and trastuzumab and pertuzumab

Neoadjuvant therapy base on PTC drug screenning

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive breast cancer
• HER2 positive
• T2 or node positive
• ECOG 0-1

You may not qualify if:

• stage IV
• inflammatory breast cancer
• Severe chronic disease

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; Trastuzumab; pertuzumab; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Study Officials

• Shu Wang, doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaobin Wang

CONTACT

+86 010 88324010; hzwcb1990@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 11, 2021
• Study Start: March 28, 2021
• Primary Completion: June 30, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CN (1)