A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

Last updated: June 5, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Breast Cancer

Cancer

Treatment

CL1

CH2

A

Clinical Study ID

NCT04215003
SCHBCC0N026
  • Ages 18-70
  • Female

Study Summary

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-70 years old Expected survival > 12 months Baseline ECOG Performance Statusrating 0-1 Naïve to chemotherapy or hormonal treatments Radiologically confirmed andbiopsy diagnosed invasive ductal carcinoma of breast and prepared to be treatedsurgically Locally advance breast cancer of stage IIb-IIIc No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)Patients have measurable lesions (according to RECIST v1.1 criteria) Intention tocooperate with baseline puncture and neoadjuvant therapy No advanced metastasis ormetastasis involving brain or liver Adequate bone marrow function, blood routineexamination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L,Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L,urea nitrogen ≤7.1mmol/L No coagulation abnormality Normal heart function, withnormal ECG and LVEF ≥ 55% Women of childbearing age agree to take reliablecontraceptive measures during clinical trials, and negative serum or urine pregnancytest within 7 days prior to administration No coagulation abnormality Sign theinformed consent statement and voluntarily receive follow-ups, treatments,laboratory tests and other research procedures according to protocol.

Exclusion

Exclusion Criteria:

  • Previous regional or systemic treatment for breast cancer (include but not limitedto chemotherapy, radiotherapy, targeted therapy, other clinical trials) Inflammatorybreast cancer, bilateral breast cancer or breast cancer already with distantmetastasis Complicated with uncontrolled lung disease, severe infection, activepeptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connectivetissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapyor related treatment Peripheral neuropathy >1 degree caused by any reason History ofcongestive heart failure, uncontrolled or symptomatic angina, arrhythmias or historyof myocardial infarction, refractory hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 100 mmHg); Breast cancer during lactation orpregnancy Unwillingly to receive baseline puncture or neoadjuvant therapy Mentalillness or incompliance to treatment caused by other reasons Known history of severehypersusceptibility to any agents used in the treatment protocol Patients receivedmajor surgery or suffered from severe trauma within 2 months of first administrationCurrently enroll or recently used (30 days within enrollment) other agent underresearch or involved in other trial Known to be infected with human immunodeficiencyvirus (HIV) Other circumstances considered to be inappropriate to be enrolled byresearchers

Study Design

Total Participants: 20
Treatment Group(s): 14
Primary Treatment: CL1
Phase: 1/2
Study Start date:
January 20, 2020
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Shao Zhimin

    Shanghai, Please Select 200032
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Active - Recruiting

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