2024-511209-49-00招募中4 期
Combination of Abemaciclib and endocrine therapy in hormone receptor positive HER2 negative locally advanced or metastatic breast cancer with focus on digital side effect management The MINERVA Trial – A phase IV Trial
Universitaetsklinikum Ulm AöR53 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2024年8月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 285
- 试验地点
- 53
- 主要终点
- The primary endpoint of this trial is progression-free survival (PFS). PFS time is measured from trial registration until the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause. Patients who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of trial registration if no post-initiation (that is, post-baseline) radiographic assessment is available.
研究概览
简要总结
The primary objective of this trial is: • Estimation of PFS, defined as the time from date of registration for the trial until progressive disease (PD) or death from any cause, whichever comes first (as defined by RECIST guideline version 1.1). If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. • PFS will be calculated separately for the following two cohorts: Cohort 1: Patients with advanced/metastatic hormone receptor positive HER2 negative breast cancer who either had received no prior endocrine treatment or had progressed more than 12 months after the end of adjuvant endocrine treatment (with or without prior adjuvant chemotherapy) Cohort 2: Patients with advanced/metastatic hormone receptor positive HER2 negative breast cancer who had progressed while receiving adjuvant endocrine treatment or less than 12 months after the end of adjuvant endocrine treatment (with or without prior adjuvant chemotherapy)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Recruitment period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have given written informed consent prior to any trial-specific procedures
- •If CNS metastases are known these have to be stable (radiotherapy finished for more than 14 days ago, no required steroid medication with more than 4 mg Dexamethasone per day)
- •Pre- and postmenopausal patients are allowed. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Women of Childbearing Potential whose male partners are potentially fertile (e.g. no vasectomy) must use highly effective contraception methods for the duration of the trial and for at least 3 weeks after last dose of drugs used in the trial. Women of childbearing potential must use highly effective contraception methods for two years after the last dose of fulvestrant. Highly effective birth control methods that results in a failure rate of less than 1% per year include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation , intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the patient.
- •No prior therapy for metastatic disease (except for first line endocrine therapy for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
- •Previous adjuvant endocrine therapy and (neo)adjuvant chemotherapy is allowed.
- •Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or ≤ Grade 2 peripheral neuropathy prior to registration. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy).
- •Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 7-14 days (at discretion of the investigator) is required between end of radiotherapy and registration.
- •One of the following as defined by the RECIST v
- •1: a. Measurable disease. At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1). Tumor evaluation according to RECIST version 1.1 (based on local assessment) has to be performed within 28 days before trial registration. However, prior CT obtained as part of routine clinical case within 12 weeks prior to trial registration is also acceptable. b. Nonmeasurable bone-only disease (must be evaluable, but not necessarily measurable by RECIST). Nonmeasurable bone-only disease may include any of the following: blastic bone lesion, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.
- •The patient has adequate bone marrow and organ function evidenced within 14 days before trial registration for all of specific criteria (please refer to protocol)..
- •The patient is able to swallow oral medications.
- •Willingness to use the provided CANKADO digital health application to report side effects and patient reported outcomes (The use of the CANKADO app is not mandatory for study participation, but is strongly recommended.
- •Are reliable, willing to be available for the duration of the trial and are willing to follow trial procedures
- •Negative pregnancy test before trial registration for women of childbearing potential and highly effective contraception if the risk of conception exists and a negative serum pregnancy test within 7 days after the first dose of trial treatment.
- •Are female and aged ≥ 18 years
- •Diagnosis of HR+, HER2- breast cancer. The primary tumor has been confirmed as HER2-negative and hormone receptor positive breast cancer by histopathology, immunohistochemistry (IHC) or in-situ hybridization (ISH) according to local testing. If HER2 status of metastatic lesion is known this has to be HER2 negative.
- •To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).
- •To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP guidelines (Wolff et al. 2013).
- •Have locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- •Indication for endocrine based therapy in the metastatic setting
- •Have a performance status (PS) of ≤ 2 on the ECOG scale
排除标准
- •Visceral crisis or life expectancy < 6 months
- •Females who are pregnant or lactating
- •Legal incapacity or limited legal capacity
- •History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
- •The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating trial treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- •Prior systemic anti-cancer therapy within the last 21 days prior to trial registration, except for first-line endocrine therapy in metastatic or locally advanced disease for max 3 months.
- •Radiotherapy within the last 7-14 days prior to registration
- •Patient has had major surgery within 14 days prior to trial registration.
- •History of hypersensitivity reactions attributed to Abemaciclib or to other components of drug formulation
- •Prior treatment with chemotherapy in the metastatic setting or endocrine therapy in the metastatic setting (except for first line endocrine therapy in metastatic or locally advanced disease for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
- •Patient not eligible for endocrine based therapy
- •Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
- •The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this trial (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- •Prior treatment with a CDK 4/6 inhibitor for metastatic or locally advanced disease. (first-line treatment with a CDK 4/6 inhibitor (Ribociclib/Palbociclib) in the metastatic setting is allowed only if terminated due to toxicity after max 3 months and no progression occurred before study entry. Prior treatment with a CDK 4/6 inhibitor in the neo-/adjuvant setting is allowed.)
- •Treatment with any other investigational agents within four weeks or 5 half-lives prior to trial registration, whichever is longer
- •The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
结局指标
主要结局
The primary endpoint of this trial is progression-free survival (PFS). PFS time is measured from trial registration until the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause. Patients who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of trial registration if no post-initiation (that is, post-baseline) radiographic assessment is available.
The primary endpoint of this trial is progression-free survival (PFS). PFS time is measured from trial registration until the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause. Patients who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of trial registration if no post-initiation (that is, post-baseline) radiographic assessment is available.
次要结局
- Overall Survival (OS)
- Objective Response Rate (ORR)
- Clinical Benefit Rate (CBR)
研究者
Prof. Dr. med. Brigitte Rack
Scientific
Universitaetsklinikum Ulm AöR
研究点 (53)
Loading locations...
相似试验
招募中
3 期
Study comparing two standard treatments as initial metastatic treatment among patients with visceral metastasis of ER+ HER2- breast cancer, high burden disease: chemotherapy and combination of hormonotherapy with abemaciclib.2024-513005-31-00Unicancer180
招募中
4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)2024-515497-26-00Medical University Of Graz33
招募中
3 期
A randomized, controlled, open-label, phase III-trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) intermediate to high risk, HR+/HER2- early breast cancer (ADAPTlate)2023-509242-35-00WSG Westdeutsche Studiengruppe GmbH1,700
尚未招募
3 期
Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast CancerBreast Cancer2024-513540-29-00Alliance Foundation Trials LLC303
进行中（未招募）
1/2 期
A study to test the effect of Samuraciclib in Combination with Elacestrant in Participants with Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-) breast cancerBreast Cancer2023-503846-30-00Carrick Therapeutics Limited48