A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
NCT ID: NCT02897700
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2013-01-31
2027-12-31
Brief Summary
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Detailed Description
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Once found, IDC usually has already broken through the wall of the milk duct and begun to invade the tissues of the breast. Over time, IDC can spread to the lymph nodes and possibly to other areas of the body with high frequency.
According to the statistics of American Cancer Society, more than 180,000 women in the United States are diagnosed with IDC each year. Although IDC can affect women at any age, it is more common as they grow older. Further, approximately two-thirds of women are 55 or older when they are diagnosed with such this symptom.
The treatments for invasive ductal carcinoma fall into two broad categories. First, local treatments for IDC, including surgery and radiation, which treat the primary tumor and surrounding areas such as the chest and lymph nodes. Second, systemic treatments for IDC, including chemotherapy, hormone therapy and targeted therapy, which are supposed to deliver cytotoxicity throughout the body to eliminate any cancer cells that have left the primary site and to help minimize the risk of recurrent disease.
PURPOSE: This randomized phase I trial is to determine the safety, tolerability and efficacy of single or concurrent administration of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) to women undergoing surgery for infiltrating ductal carcinoma in situ breast cancer.
RATIONALE: This is a randomized, controlled, open-labeled and multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms A or B). Patients accrued as control participants are assigned to arm C. to implement the study, the investigators will collect surgical samples of the primary tumor and periphery blood from breast cancer patients to assess the effects of chemotherapeutic regimens and correlation with post-therapy survival in the patient cohorts. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also analyze and evaluate the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to confirm the treatment efficacy and appraise the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mono-chemotherapy
A mono-chemotherapy (a single chemotherapeutic agent out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (or CDEFM) was performed 30\~60 days prior to surgery for patients who had no history of receiving either local or systemic cancer-associated chemotherapy.
Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate.
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.
Combined chemotherapy
Combined chemotherapy (random combination of two breast cancer chemotherapeutic agents including cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, or CDEFM) was performed 30\~60 days prior to surgery for patients who had no history of receiving either local or systemic chemotherapy for cancer.
Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate.
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 treatment
No chemotherapeutic regimes using any cytotoxic agent was done for patients who have infiltrating ductal carcinoma of breast. Placebo was used instead.
Placebo
Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Shanghai 10th People's Hospital
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Ganzhou City People's Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Yu Sun
Professor
Principal Investigators
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Yu Sun, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Ganzhou City People's Hospital
Ganzhou, Jiangxi, China
China-Japan Union Hospital, Jilin University
Changchun, Jilin, China
Shanghai 10th People's Hospital, Tongji University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCA-81472709
Identifier Type: -
Identifier Source: org_study_id
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