2024-511141-19-00招募中2 期
Use of Imatinib to convert triple negative breast cancer into ER-positive breast cancer: I-CONIC
Vaestra Goetalandsregionen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunohistochemistry fraction of Estrogen Receptor is changed from 0% to 2% or more after imatinib treatment
研究概览
简要总结
To determine the proportion of patients that converts to Estrogen Receptor (ER)-positive breast cancer in the removed breast cancer tissue at surgery
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed invasive primary triple negative breast cancer (≥15 mm) with any node status.
- •Female patients of childbearing potential must agree to use contraceptive methods with a failure rate below 1% per year during the study treatment and at least 90 days after the last dose of imatinib
- •Patients must be able to take (swallow) an oral medication
- •Patients must be capable to understand and comply with the protocol and has signed the informed consent
- •Age ≥ 18 years old
- •Triple negative breast cancer subtype defined as ER- and PR-negative [staining present in <10% by immunohistochemistry (IHC), and HER2-negative defined by the ASCO CAP guidelines]
- •No previous systemic treatment for TNBC
- •No concurrent anti-cancer treatment
- •Treatment with Bisphosponates may continue
- •ECOG performace status 0-1
- •Normal organ function defined as follows: absolute white blood cell count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, haemoglobin ≥90 g/dL, total bilirubin ≤1.5 x institutional UNL/dL (≤3 x UNL for patients with Gilbert´s sydrome), ASAT, ALAT, GGT and alkaline phosphatase levels <1.5 x institutional ULN, albumin >2.5 mg/dL, Creatinine <110 µmol/L, T3, T4 and TSH (only patients with previous thyroid dysfunction)
- •Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy
排除标准
- •Patients suitable for neoadjuvant treatment / inclusion in NordicTRIP
- •HER2 positive or luminal (ER/PR positive) breast cancer
- •Concomitant treatment for breast cancer within 14 days before registration
- •Unable to adhere to the study procedures
- •Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance
- •Pregnancy and breast feeding
- •Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitely treated ≥ 5 years before inclusion with no subsequent evidence of recurrence)
- •Known human immune deficiency positivity
- •Known active Hepatitis B or Hepatitis C
结局指标
主要结局
Immunohistochemistry fraction of Estrogen Receptor is changed from 0% to 2% or more after imatinib treatment
Immunohistochemistry fraction of Estrogen Receptor is changed from 0% to 2% or more after imatinib treatment
Immunohistochemistry fraction of Estrogen Receptor is changed from 1-9% to ≥10% after imatinib treatment
Immunohistochemistry fraction of Estrogen Receptor is changed from 1-9% to ≥10% after imatinib treatment
Immunohistochemistry fraction of Estrogen Receptor 1-9% increase with at least 2%, coupled with a significant increase luminal gene transcripts
Immunohistochemistry fraction of Estrogen Receptor 1-9% increase with at least 2%, coupled with a significant increase luminal gene transcripts
次要结局
- Safety analyses according to common terminology criteria for adverse events (CTCAE) v.5: up to 30 days after the last dose of imatinib.
- Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, intrinsic subtypes and proliferation) and immune response in tissue and blood before start of imatinib and in the surgical specimen.
研究者
Barbro Linderholm
Scientific
Vaestra Goetalandsregionen
研究点 (1)
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