NL-OMON51870招募中3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer - MK3475-B49
Merck Sharp & Dohme (MSD)0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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 64（—）
入选标准
- •The main inclusion criteria are listed here. For a complete list of inclusion
- •please refer to the research protocol.
- •1. Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer,
- •which has not been previously treated with cytotoxic chemotherapy in the
- •noncurative setting.
- •2. Has progressed on prior endocrine therapy and is now a chemotherapy
- •candidate, meeting the characteristics in regard to previous treatments of one
- •of the 4 groups.
- •3. Has presented a documented radiographic disease progression
- •4. Is a chemotherapy candidate that meets the criteria as described in the
- •5. Provides a new or the last obtained core biopsy.
- •6. Has centrally confirmed PD-L1 CPS >=1 and HR+ (ER and/or PgR) /HER2- breast
- •cancer as defined by the most recent ASCO/CAP guidelines on most recent tumor
- •7. Has an ECOG Performance Status of 0 or 1, as assessed within 7 days prior to
- •the first dose of study treatment.
- •8. Demonstrates adequate organ function, within 10 days prior to the start of
- •study treatment, as defined in the protocol.
- •9. Participants are at least 18 years of age on the day of signing informed
- •10. Male participants are eligible to participate if they agree to the criteria
- •as defined in the protocol during the study intervention period and for at
- •least 6 months after the last dose of chemotherapy.
- •11. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least 1 of the conditions defined in the protocol.
- •12. The participant (or legally acceptable representative if applicable)
- •provides documented informed consent for the study.
排除标准
- •The main exclusion criteria are listed here. For a complete list of exclusion
- •please refer to the research protocol.
- •1. Has breast cancer amenable to treatment with curative intent.
- •2. Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality as defined in the protocol.
- •3. Has significant cardiac disease as defined in the protocol
- •4. Has advanced/metastatic, symptomatic visceral spread at risk of rapidly
- •evolving into life-threatening complications, see more information in the study
- •5. Has skin only disease. Participants who have metastatic disease fulfilling
- •the previous criteria in addition to skin disease can be enrolled.
- •6. Has a known germline BRCA mutation and has not received previous treatment
- •with PARP inhibition either in the adjuvant or metastatic setting. Single-agent
- •PARP inhibitor therapy does not count as a line of endocrine therapy.
- •7. Has received prior chemotherapy for locally recurrent inoperable or
- •metastatic breast cancer.
- •8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
- •agent or with an agent directed to another stimulatory or coinhibitory T-cell
- •receptor (eg, CTLA-4, OX-40, CD137).
- •9. Has received prior systemic anticancer therapy with other investigational
- •agents within 4 weeks prior to randomization.
- •10. Has received prior radiotherapy within 2 weeks of start of study
- •intervention or radiation-related toxicities requiring corticosteroids.
- •11. Has received a live or live attenuated vaccine within 30 days prior to the
- •first dose of study intervention.
- •12. Has received an investigational agent or has used an investigational device
- •within 4 weeks prior to study intervention administration.
- •13. Has a diagnosis of immunodeficiency or is receiving chronic systemic
- •steroid therapy or any other form of immunosuppressive therapy as defined in
- •the protocol.
- •14. Has a known additional malignancy that is progressing or has required
- •active treatment within the past 3 years.
- •15. Has known active CNS metastases as defined in the protocol.
研究者
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