CTIS2024-510776-20-00招募中1 期
POLAR: A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer - IBCSG 59-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence of a primary invasive breast cancer in at least one of the sites below: – Breast – Chest wall including mastectomy scar and/or skin – Axillary or internal mammary lymph nodes - Completion of locoregional therapy: – Completion of gross excision of recurrence within 6 months prior to randomization – Completion of radiotherapy (if given) more than 2 weeks prior to randomization - Negative or microscopically involved margins - Female or male aged 18 years or older - ECOG performance status 0 or 1 - Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ =1% by IHC - Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified) Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH/FISH - Normal hematological, renal, and liver function - The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review - Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence - Written Informed Consent (IC) prior to randomization
排除标准
- •- Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable - Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy or FDG-PET-CT). - Bilateral synchronous or metachronous invasive breast cancer (in situ carcinoma of the contralateral breast is allowed) - Inflammatory breast cancer - Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions: – Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible – Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers - Previous treatment with palbociclib or any other CDK 4/6 inhibitors - Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization) - Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety - Contraindications or known hypersensitivity to the palbociclib or excipients - History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. History of prior radiation pneumonitis is not an exclusion criterion. - Pregnant or lactating women; lactation has to stop before randomization
研究者
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