Actively Recruiting
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-04-17
300
Participants Needed
3
Research Sites
778 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shanghai 10th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe, tolerable, and effective in the treatment of patients with infiltrating ductal carcinoma of breast.
CONDITIONS
Official Title
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older with confirmed infiltrating ductal carcinoma of breast
- No severe major organ dysfunction
- Adequate blood cell counts: WBC ≥ 3,000/μl, ANC ≥ 1,500/μl, Platelets ≥ 100,000/μl, Hemoglobin ≥ 10 g/dl and not needing transfusion
- Liver enzymes ALT and AST no more than 10% above normal limits
- Negative pregnancy test within 72 hours before starting treatment for women who can become pregnant
- World Health Organization performance status of 0 or 1
- No previous or current chemotherapy for cancer and no new hormone therapy started
- Clinical Stage I subtype A breast cancer without distant metastasis as confirmed by imaging
- Willing and able to provide written informed consent
You will not qualify if you...
- Under 18 years of age
- Severe major organ dysfunction
- World Health Organization performance status greater than 1
- Previous cancer chemotherapy
- Stage IV breast cancer
- Symptomatic central nervous system metastases from breast cancer
- History of another invasive cancer within the last 3 years
- History of loss of consciousness or transient ischemic attack within 12 months before starting treatment
- Known active HIV, Hepatitis B, or Hepatitis C infections
- Any other condition that would make participation unsafe or unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Ganzhou City People's Hospital
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
2
China-Japan Union Hospital, Jilin University
Changchun, Jilin, China, 130033
Actively Recruiting
3
Shanghai 10th People's Hospital, Tongji University School of Medicine
Shanghai, China, 200072
Actively Recruiting
Research Team
Y
Yu Sun, Ph.D
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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