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New treatment option for Breast Cancer
Official title A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
ClinicalTrials.gov ID: NCT02897700
What this study is testing
What is Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate?
Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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.
You likely can't join 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
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ganzhou, Jiangxi, China
- Changchun, Jilin, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ganzhou, Jiangxi, China; Changchun, Jilin, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.