Recruiting
Phase 1
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexatecyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)Placebo
Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate: Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM): Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30\~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
Placebo: Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.
Study summary
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.
Eligibility
Inclusion Criteria:
* Patients ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast
* no severe major organ dysfunction
* Patients must have adequate hematopoietic function as evidenced by:
white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transfusion dependent
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal
* Individuals of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1.
* World Health Organization (WHO) performance status of 0 or 1
* No prior or concurrent cancer-associated chemotherapy, no initiation of new hormonal therapy
* Hormone receptor (estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2)) status not specified
* Menopausal status not specified
* Patients or their legal representatives must be willing and able to provide written informed consent
* A Clinical Stage ≥ I subtype A (IA) (T1a, N0, M0) of Beast Cancer but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer-PrimaryTumor, Regional Nodes and Metastasis (TNM) staging system) as determined by a preoperative evaluation that included a chest computed tomography (CT) scan and/or X-ray mammography.
Exclusion Criteria:
* Age \< 18
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy
* Stage IV
* Patients with symptomatic central nervous system (CNS) metastases from breast cancer
* Patients with a history of another invasive malignancy within the last 3 years
* History of loss of consciousness or transient ischemic attack within 12 months before study treatment initiation.
* Patients who have known active HIV, Hepatitis B, or Hepatitis C infections.
* Patients with any other condition which in the opinion of the investigator would preclude participation in the study.
Primary outcome measure(s)
- Incidence of treatment-emergent adverse events — 6 months
The case of emergent events caused by treatment is measured by counting the blood cell number and detecting liver and kidney functions. Total blood cell number, alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) \> 20% above upper limit of normal, is considered as not safe.
Tolerability is measured by monitoring the first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) (NCI-CTC version 4; or CTCAE v4.0) and/or disruption of chemotherapy because of inacceptable toxicity.
Chemotherapeutic efficacy is measured by the remaining tumor size after computed tomography (CT) scanning and comparing it with the original primary tumor size 2-3 weeks after last cycle of chemotherapy. The ratio of post-treatment tumor size to pre-treatment tumor size \< 50% is considered as effective. Otherwise not.
Trial sites (3)
| Facility | City | Region | Status |
|---|
| Ganzhou City People's Hospital |
Ganzhou |
Jiangxi |
Recruiting |
| China-Japan Union Hospital, Jilin University |
Changchun |
Jilin |
Recruiting |
| Shanghai 10th People's Hospital, Tongji University School of Medicine |
Shanghai |
China |
Recruiting |
More Shanghai Jiao Tong University School of Medicine trials in China
Other trials for the same condition