Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Bre… (NCT04293393) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
Spain200 participantsStarted 2020-10-02
Plain-language summary
Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast cancer patients
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent prior to any specific study procedures.
✓. Women ≥ 18 years of age.
✓. Documentation of histologically confirmed primary invasive adenocarcinoma of the breast.
✓. Availability of a primary tumor tissue sample obtained during the diagnostic process before treatment for the central assessment of Ki67 index.
✓. Documentation of Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative Breast Cancer (BC) based on local laboratory determination.
✓. Intermediate and high risk patients based on Ki67 index value (≥ 20%) determined at a central laboratory.
✓. Patients should be in the following clinical stages of disease according to the 8th edition of the TNM Classification of Breast Cancer by the Union for International Cancer Control (UICC): T2 (\> 2cm) - T3, T4b, N0 - N2, M0 (stages IIA, IIB, IIIA or IIIB). Subpopulation with tumors T2 N0 M0 will include high risk patients based on Ki67 index \> 30% or Ki67 index between 20-30% and PgR negative with or without histological grade 3.
✓. Patients diagnosed with multifocal or multicentric breast cancer will be eligible for the study if only 2 tumor lesions have been confirmed in the clinical evaluation and both lesions comply with the characteristics required by the protocol (please, refer to previous inclusion criteria).
Exclusion criteria
✕. Previous anti-cancer treatment with therapeutic intent for current breast cancer is not allowed.
What they're measuring
1
Residual Cancer Burden (RCB) 0-I Rate
Timeframe: Through study treatment, and average of 12 months
. Inflammatory breast cancer, multifocal/multicentric breast cancer with ≥ 3 tumor lesions or synchronous bilateral invasive breast cancers are not eligible.
✕. Serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (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).
✕. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
✕. Females who are pregnant or lactating.
✕. Active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study 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.
✕. 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.
✕. Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or colorectal.