BridgeMD
Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer.
EU CTIS ID: 2024-514395-40-00
What this study is testing
To assess the Residual Cancer Burden (RCB) 0-I rate in both treatment arms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Written informed consent prior to any specific study procedures.
- 10. At the time of presentation, patients must be candidates for potentially curative surgery by surgeon’s assessment.
- 11. Sentinel lymph node biopsy (SLNB) will be preferable after the neoadjuvant treatment. Those patients with SLNB before the neoadjuvant treatment will be eligible for the study only if the SLNB has a negative result (N0). One Step Nucleic Acid Amplification (OSNA) method is not allowed.
- 12. Pre- and postmenopausal women. Postmenopausal status is defined as: • Patient underwent bilateral oophorectomy, or • Age ≥ 60 years, or • Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.
- 13. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- 14. Patients are able to swallow oral medications.
You likely can't join if
- 1. Previous anti-cancer treatment with therapeutic intent for current breast cancer is not allowed.
- 10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- 2. Patients with inflammatory breast cancer or synchronous bilateral invasive breast cancers are not eligible.
- 3. 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).
- 4. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
- 5. Females who are pregnant or lactating.
See the full eligibility criteria
Who can join
- 1. Written informed consent prior to any specific study procedures.
- 10. At the time of presentation, patients must be candidates for potentially curative surgery by surgeon’s assessment.
- 11. Sentinel lymph node biopsy (SLNB) will be preferable after the neoadjuvant treatment. Those patients with SLNB before the neoadjuvant treatment will be eligible for the study only if the SLNB has a negative result (N0). One Step Nucleic Acid Amplification (OSNA) method is not allowed.
- 12. Pre- and postmenopausal women. Postmenopausal status is defined as: • Patient underwent bilateral oophorectomy, or • Age ≥ 60 years, or • Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.
- 13. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- 14. Patients are able to swallow oral medications.
- 15. Adequate organ and bone marrow function: • ANC ≥ 1,500/mm3 (1.5x109/L); • Platelets ≥ 100,000/mm3 (100x109/L); • Hemoglobin (Hgb) ≥ 8g/dL (80g/L) (erythrocyte transfusions are permitted; initial treatment must not begin earlier than the day after the erythrocyte transfusion); • Total serum bilirubin ≤ 1.5xULN (≤ 2xULN and direct bilirubin within normal limits if Gilbert´s disease); • AST and ALT ≤ 3xULN.
- 16. Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).
- 17. For premenopausal women: agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 weeks after the last dose of study treatment. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide.
- 18. Negative serum pregnancy test within 7 days of the first dose of abemaciclib or chemotherapy for premenopausal women, and for women who have experienced menopause onset < 12 months prior to first dose of therapy.
- 19. Patients consent to biological sample provision for biomarker exploratory analyses.
- 2. Women ≥ 18 years of age.
- 20. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- 3. Documentation of histologically confirmed primary invasive adenocarcinoma of the breast. Adenocarcinoma with another component of epithelial origin (for example, medullary or neuroendocrine) is allowed.
- 4. Availability of a primary tumor tissue sample obtained during the diagnostic process before treatment for the central assessment of Ki67 index and biomarker exploratory analyses (following the specifications described in the Sample Management Manual of the study).
- 5. Documentation of HR positive and HER2 negative BC based on local laboratory determination. a. HR positive is defined as more than or equal to 10% positive cells by IHC for ER and/or progesterone receptor (PgR). b. HER2 negative tumor is determined according to recommendations of ASCO/CAP 2018 guidelines.
- 6. Intermediate and high risk patients based on Ki67 index value (≥ 20%) determined at a central laboratory.
- 7. Patients should be in the following clinical stages of disease according to the 8th edition of the TNM Classification of Breast Cancer by the UICC (Union for International Cancer Control): T1c N1-2 M0 and T2 (> 2cm) – T3, T4a, 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% and < 30% if PgR negative and/or histological grade 3.
- 8. Patients with diagnosis of suspicious for multifocal or multicentric breast cancer will be eligible for the study.. At least two tumor lesions should be biopsied. All histologically available tumor lesions must comply with the inclusion criterion no. 5. a. If all lesions have similar morphological characteristics (i.e. based on local assessment of type, grade, Ki67 index level, etc.…), only the largest tumor lesion will be assessed for central assessment of Ki67 index level. b. If lesions have different morphological characteristics, discordant tumor lesions will be centrally evaluated for Ki67 index level. Patients will be eligible if at least one tumor lesion complies with criteria 6 and 7.
- 9. Indication of neoadjuvant treatment.
What rules you out
- 1. Previous anti-cancer treatment with therapeutic intent for current breast cancer is not allowed.
- 10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- 2. Patients with inflammatory breast cancer or synchronous bilateral invasive breast cancers are not eligible.
- 3. 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).
- 4. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
- 5. Females who are pregnant or lactating.
- 6. 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.
- 7. 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.
- 8. 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, breast or colorectal.
- 9. Prior hematopoietic stem cell or bone marrow transplantation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.