Actively Recruiting
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC
Led by Fudan University · Updated on 2024-06-06
20
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Expected survival greater than 12 months
- ECOG Performance Status of 0 or 1
- No prior chemotherapy or hormonal treatments
- Radiologically confirmed and biopsy-proven invasive ductal carcinoma of the breast
- Locally advanced breast cancer stage IIb to IIIc
- No other active cancers except controlled cervical carcinoma in situ or basal cell carcinoma of skin
- Measurable lesions according to RECIST v1.1 criteria
- Willingness to cooperate with baseline biopsy and neoadjuvant therapy
- No advanced metastasis or metastasis involving brain or liver
- Adequate bone marrow function with specified blood counts
- Adequate liver and kidney function within specified laboratory limits
- No blood clotting abnormalities
- Normal heart function with normal ECG and LVEF of at least 55%
- Women of childbearing potential agree to use reliable contraception and have negative pregnancy test within 7 days before treatment
- Signed informed consent and willingness to follow study procedures
You will not qualify if you...
- Prior regional or systemic treatment for breast cancer including chemotherapy, radiotherapy, targeted therapy, or participation in other clinical trials
- Inflammatory breast cancer, bilateral breast cancer, or breast cancer with distant metastasis
- Uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders, or bone marrow suppression
- Intolerance to neoadjuvant therapy or related treatments
- Peripheral neuropathy greater than grade 1
- History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias, myocardial infarction, or refractory hypertension
- Breast cancer during lactation or pregnancy
- Unwillingness to undergo baseline biopsy or neoadjuvant therapy
- Mental illness or inability to comply with treatment
- Known severe allergy to any treatment agents
- Major surgery or severe trauma within 2 months before first treatment
- Current or recent participation in another investigational trial within 30 days
- Known HIV infection
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Shao Zhimin
Shanghai, Please Select, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD.PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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