A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast

NCT02897700 | Recruiting Phase 1 DMC

• 1 other identifier: BCA-81472709
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

Chemotherapy; Safety; Tolerability; Efficacy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  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.

  6 months

Secondary Outcomes (1)

• Circulating concentrations of tumor microenvironment-specific soluble factors

  6 months

Study Arms (3)

Mono-chemotherapy

EXPERIMENTAL

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.

Drug: Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate

Combined chemotherapy

EXPERIMENTAL

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.

Drug: cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)

Placebo treatment

PLACEBO COMPARATOR

No chemotherapeutic regimes using any cytotoxic agent was done for patients who have infiltrating ductal carcinoma of breast. Placebo was used instead.

Drug: Placebo

Interventions

Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate DRUG

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.

Mono-chemotherapy

cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) DRUG

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.

Combined chemotherapy

Placebo DRUG

Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.

Placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai 10th People's Hospital: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• Ganzhou City People's Hospital: collaborator

Study Sites (3)

Ganzhou City People's Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

China-Japan Union Hospital, Jilin University

Changchun, Jilin, 130033, China

RECRUITING

Shanghai 10th People's Hospital, Tongji University School of Medicine

Shanghai, 200072, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Epirubicin; Fluorouracil; Methotrexate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Yu Sun, Ph.D

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Sun, Ph.D

CONTACT

86-21-54923302; sunyu@sibs.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 13, 2016
• Study Start: January 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)