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New treatment option for Tubular Breast Cancer
Official title Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
ClinicalTrials.gov ID: NCT03201861
What this study is testing
What is Paclitaxel, Cisplatin?
Paclitaxel, Cisplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for tubular breast cancer.
Also referred to as Taxol.
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 investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Women aged ≥18 years and ≤70 years
- Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
- Not received treatment for breast cancer before operation
- Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following...
- HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
You likely can't join if
- metastatic breast cancer
- Patient is pregnant or breast feeding
- Any evidence of sense or motor nerve disorders
- Bilateral Primary Breast Cancer (DCIS in one side not included)
- Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
- Have received chemotherapy because of any malignancy other than breast cancer
See the full eligibility criteria
- Women aged ≥18 years and ≤70 years
- Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
- Not received treatment for breast cancer before operation
- Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm...
- HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
- Performance status (PS) 0-1
- Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit...
- No obvious main organs dysfunction
- metastatic breast cancer
- Patient is pregnant or breast feeding
- Any evidence of sense or motor nerve disorders
- Bilateral Primary Breast Cancer (DCIS in one side not included)
- Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
- Have received chemotherapy because of any malignancy other than breast cancer
- Known severe hypersensitivity to any drugs in this study
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.