A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy

NCT04297267 | Unknown Phase 2

• 1 other identifier: 1608162-19-1805B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy.

Conditions

Triple Negative Breast Cancer

Keywords

gemcitabine; cisplatin; non-pCR; TNBC

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

  3-year

Secondary Outcomes (7)

• Recurrence free survival

  3-year

• Distant disease free survival

  3-year

• Overall survival

  3-year

• Disease free survival(5year)

  5-year

• Recurrence free survival(5year)

  5-year

Study Arms (1)

GP group

EXPERIMENTAL

Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).

Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Gemcitabine 1250mg/m2,d1,d8,every 3 weeks

GP group

Cisplatin DRUG

Cisplatin 75mg/m2,d1，every 3 weeks

GP group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years old
• Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type)
• Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition).
• After standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients.
• No gross or microscopic tumor residual after resection.
• Patients with clear ER/PR/Her2 receptor, and ER/PR/Her2 are all negative(Specific definition: immunohistochemical detection of ER \< 1% positive tumor cell is defined as the ER negative, PR \< 1% positive tumor cells is defined as the PR negative, Her2 0-1 or Her2 2 + but after FISH or CISH tested negatie for c (no amplification) is defined as the Her2-negative).
• No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M0.
• Patients without peripheral neuropathy or I peripheral neurotoxicity.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
• Patients recovered well after surgery, at least 1 weeks after the operation.
• Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL.
• Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
• Adequate renal function: Serum creatinine ≤ 1.5ULN.
• Contraception during the treatment of child-bearing women.
• Adequate cardiac function :Left ventricular ejection fraction (LVEF) \> 50%.

You may not qualify if:

• Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS).
• Metastasis of any part except axillary lymph nodes.
• Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy.
• There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer.
• Patients have been enrolled in other clinical trials.
• Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study.
• Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension \>160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization.
• Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.)
• Child-bearing women who are unwilling to take effective contraceptive measures in the course of research.
• Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial).
• Persons without personal freedom and independent civil capacity.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: February 7, 2017
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CN (1)