Neoadjuvant Phase II Study of Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer (The TELESCOPE Study)
概览
- 阶段
- 2 期
- 干预措施
- Paclitaxel
- 疾病 / 适应症
- 未指定
- 发起方
- MedSIR
- 入组人数
- 31
- 试验地点
- 11
- 主要终点
- To assess pathological complete response (pCR) rate in all patients.
- 状态
- 进行中（未招募）
- 最后更新
- 25天前
概览
简要总结
This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥10 mm and up to 25 mm by mammogram and/or ultrasound, or ≤25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.
详细描述
After signing informed consent form (ICF) and confirmed eligibility, eligible patients with localized TNBC, node-negative status, and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer (N=30) will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery as indicated below: * Pembrolizumab: 200 mg, every three weeks (Q3W), intravenously (IV) on day 1 (D1) of each cycle. * Carboplatin: area under the curve (AUC) 1.5, IV on D1, D8 and D15 of each 21-days cycle. * Paclitaxel: 80 mg/m2, IV on D1, D8 and D15 of each 21-days cycle. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected, until end of study (EoS) or study termination, whichever occurs first.
研究者
Alicia Garcia (Chief Scientific Officer)
Scientific
Medica Scientia Innovation Research S.L.
入排标准
入选标准
- •Written informed consent form (ICF) prior to beginning specific protocol procedures.
- •Female or male patients ≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Histologically confirmed TNBC as defined by the most ASCO/CAP guidelines based on local laboratory results.
- •Note: TNBC means tumors that have \<1 percent expression of Estrogen Receptor (ER) and Progesterone Receptor (PR) as determined by immunohistochemistry (IHC), and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative.
- •Node-negative status by clinical exam and local radiological evaluation.
- •Bilateral tumors and/or multi-focal (e.g, 2, separate lesions in the same quadrant)/multi-centric (e.g, 2 separate lesions in different quadrants) tumors are allowed. The tumor with the most advanced T stage should be used to assess the eligibility and TNBC needs to be confirmed for each breast/focus. In these cases, both axillae need to be assessed for nodal involvement confirmation.
- •No evidence of metastatic disease based on radiological assessment according to institutional practices.
- •No previous definitive ipsilateral breast surgery for the current breast cancer.
- •No prior chemotherapy, targeted therapy, and/or radiation therapy with therapeutic intent for this cancer.
排除标准
- •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 co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- •Has received prior systemic anti-breast cancer therapy, including an investigational agents or has used an investigational device within 4 weeks prior to allocation.
- •Has received prior taxane or platinum-based therapy.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Has had an allogenic tissue/solid organ transplant.
- •Has a history of invasive malignancy within the last 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
- •Participation in an interventional clinical study within 4 weeks of first dose of study treatment.
- •Major surgical procedure or significant traumatic injury within 14 days prior to enrolment or anticipation of need for major surgery within the course of the study treatment.
- •Has received a live vaccine within 30 days of first dose of study treatment.
- •Active autoimmune disease that has required systemic treatment in past 2 years, or ANY diagnosis of immunodeficiency or is receiving systemic steroid therapy (e.g, dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Replacement therapy (e.g, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
研究组 & 干预措施
Pembrolizumab and Carboplatin plus Paclitaxel
Patients will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.
干预措施: Paclitaxel
Pembrolizumab and Carboplatin plus Paclitaxel
Patients will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.
干预措施: Carboplatin
Pembrolizumab and Carboplatin plus Paclitaxel
Patients will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.
干预措施: Pembrolizumab
结局指标
主要结局
To assess pathological complete response (pCR) rate in all patients.
时间窗: From baseline up to 84 days (the date of breast surgery).
To evaluate the pCR rate defined as the percentage of patients with ypT0/is, ypN0 at surgery based on local assessment. The efficacy will be evaluated by pCR rates concerning breast and lymph nodes (pCR breast + lymph node) in the overall population.
次要结局
- To assess pathological complete response (pCR) rate according to PD-L1 status.(From baseline up to 84 days (the date of breast surgery).)
- To evaluate residual cancer burden (RCB) at surgery.(At breast surgery.)
- To evaluate the incidence of adverse events [Safety and Tolerability].(From baseline up to 84 days (the date of breast surgery).)