NCT07643428尚未招募2 期
Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Patients will be treated with a dietary supplement enriched with omega-3 PUFA (O3Supp) for 4 to 28 weeks prior to surgical resection of a breast tumor(s). Concurrent standard-of-care neoadjuvant treatment with clinically indicated systemic agents (such as chemotherapy, endocrine therapy, anti-HER2 therapy, immunotherapy) is allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥18 years of age.
- •Breast tumor ≥1 cm.
- •Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted.
- •Unilateral and/or bilateral diagnostic breast mammogram and/or ultrasound within 60 days of enrollment. If breast MRI is done per treating physician's discretion, at least one breast imaging modality should be within 60 days of enrollment.
- •Pathologically proven diagnosis of invasive breast cancer, clinical stage I-III (cT1c-T4, N0-N3, M0).
- •Concurrent (neoadjuvant) systemic anti-cancer therapy is planned, including but not limited to endocrine therapy, chemotherapy, anti-HER2 therapy, and immunotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Bilateral breast cancer and/or multifocal, multicentric disease is allowed.
- •Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history/physical examination, including breast exam (inspection and palpation of the breasts), within 30 days prior to study entry.
- •Patients with a prior history of breast cancer will be considered eligible.
- •Surgical candidacy as determined by the treating physician.
- •Patient must provide study-specific informed consent prior to study entry or have a legally authorized representative provide consent.
排除标准
- •American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).
- •Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- •Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.
研究者
Lubna Chaudhary
Associate Professor
Medical College of Wisconsin
研究点 (1)
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