A Prospective, Non-Randomised, Open-Label, Cohort Clinical Study to Evaluate the Safety and Efficacy of Ayurvedic Formulation MVT Tablets in Combination with Standard Chemotherapy in Female Patients with Stage 0–2 Invasive Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Radiographic evaluation will be conducted as per the Response Evaluation Criteria in Solid Tumors (RECIST), which includes the following assessments,
研究概览
简要总结
The current study is designed to comprehensively evaluate the safety and efficacy of the Ayurvedic formulation MVT Tablets in female patients diagnosed with Stage 0–2 invasive breast cancer. The primary objectives include assessing the safety and tolerability of MVT Tablets when administered in combination with standard chemotherapy, and investigating its efficacy in terms of clinical response rate in the target population. This includes monitoring tumor regression, treatment-related adverse events, and overall therapeutic benefit. The secondary objectives aim to explore the herb–drug compatibility, understand potential immunemodulatory effects, and evaluate improvements in quality of life during chemotherapy. This trial utilizes a synergistic polyherbal composition, including Aegle marmelos (Bilwa) 300 mg, Ocimum sanctum (Tulasi) 100 mg, Curcuma longa (Haridra) 25 mg, Piper nigrum (Marica) 25 mg, and Tinospora cordifolia (Seenthil) 50 mg each selected for its traditionally recognized anticancer, anti-inflammatory, and immunomodulatory properties. By integrating these botanicals into standard cancer care, the study seeks to explore holistic, integrative approaches for managing breast cancer and improving patient outcomes. This ongoing study aims to provide foundational clinical data, bridging traditional knowledge with modern oncology, and paving the way for further development of integrated therapeutic strategies that align with patient-centered, personalized care in breast cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged between 18 and 65 years, with a pathologically confirmed diagnosis of invasive breast carcinoma
- •Patients with documented HER-2/Neu status, either negative or positive
- •Patients presenting with bi-dimensionally measurable and evaluable disease lesions
- •Patients showing no evidence of disease beyond the breast or chest wall, except for involvement of ipsilateral axillary lymph nodes
- •Patients with a life expectancy of at least 6 months at the time of screening
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Patients with a chest CT scan at screening that shows no evidence of metastatic disease
- •Patients who are willing and able to provide written informed consent prior to study participation
- •Patients of childbearing potential who agree to use effective contraceptive methods throughout the study duration and for at least 3 months following its completion
- •Patients must have baseline laboratory values within the following acceptable ranges at screening: white blood cell count less than or equal to 3000/mm³ absolute neutrophil count less than or equal to 2000/mm³ hemoglobin concentration less than or equal to 8 g/dL, platelet count less than or equal to 100,000/mm³; serum creatinine greater than or equal to 1.5 times the upper normal limit (UNL), alkaline phosphatase greater than or equal to 1.5 × UNL; total serum bilirubin greater than or equal to 1.5 × the institutional UNL; serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 1.5 × UNL; and serum calcium within the institution-defined normal range
- •Patients with a negative pregnancy test result at the time of screening.
排除标准
- •Patients with prior systemic treatment for breast cancer, including hormonal therapy, chemotherapy, or any other form of anticancer therapy
- •Patients who have received prior radiation therapy
- •Patients who have received, are currently receiving, or are scheduled to receive post-operative radiotherapy
- •Patients with a history of any malignancy other than breast cancer
- •Patients currently taking alternative therapies for cancer must discontinue such therapies prior to enrolment with appropriate washout period, alternative therapies are not permitted during either the treatment or follow-up phases of the study
- •Patients with peripheral neuropathy of Grade 2 or higher
- •Patients with electrocardiogram (ECG) findings that show significant abnormalities, as determined by the investigator
- •Patients who are medically unstable, including but not limited to those with active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, or superior vena cava syndrome.
结局指标
主要结局
1. Radiographic evaluation will be conducted as per the Response Evaluation Criteria in Solid Tumors (RECIST), which includes the following assessments,
时间窗: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) | Time frame: Visits 4, 6, and 8 | -CT imaging | Time frame: visits 4,6, and 8 | -Tumor markers (HER2, CA15-3, CA27-29) | Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). | and histological assessment at Screening Visit | 2. Quality of life will be evaluated at two key time points | Time frame: baseline and end of study (EOS)
a. Chest computed tomography (CT) imaging for evaluation of clinical lesions.
时间窗: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) | Time frame: Visits 4, 6, and 8 | -CT imaging | Time frame: visits 4,6, and 8 | -Tumor markers (HER2, CA15-3, CA27-29) | Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). | and histological assessment at Screening Visit | 2. Quality of life will be evaluated at two key time points | Time frame: baseline and end of study (EOS)
b. CT imaging for objective tumor response evaluation.
时间窗: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) | Time frame: Visits 4, 6, and 8 | -CT imaging | Time frame: visits 4,6, and 8 | -Tumor markers (HER2, CA15-3, CA27-29) | Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). | and histological assessment at Screening Visit | 2. Quality of life will be evaluated at two key time points | Time frame: baseline and end of study (EOS)
c. Tumor markers (HER2, CA15-3, CA27-29) and histological assessment.
时间窗: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) | Time frame: Visits 4, 6, and 8 | -CT imaging | Time frame: visits 4,6, and 8 | -Tumor markers (HER2, CA15-3, CA27-29) | Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). | and histological assessment at Screening Visit | 2. Quality of life will be evaluated at two key time points | Time frame: baseline and end of study (EOS)
2. Improvement in Quality of life (SF-36) comparing baseline with end of study.
时间窗: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) | Time frame: Visits 4, 6, and 8 | -CT imaging | Time frame: visits 4,6, and 8 | -Tumor markers (HER2, CA15-3, CA27-29) | Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). | and histological assessment at Screening Visit | 2. Quality of life will be evaluated at two key time points | Time frame: baseline and end of study (EOS)
次要结局
- 1. NCI (National Cancer Institute) toxicity criteria at every(course-adverse events were summarized by NCI CTC (Common Toxicity Criteria).)
研究者
Dr K Velavan
Erode Cancer Centre