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New treatment option for HR+/HER2+ Early Breast Cancer
Official title Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
ClinicalTrials.gov ID: NCT07616427
What this study is testing
What is Fovinaciclib?
Fovinaciclib is an investigational medicine, being studied as a potential treatment for hr+/her2+ early breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- people voluntarily agree to participate in the study, fully understand the study procedures, provide written informed consent (ICF), and are willing...
- Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage...
- Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
- Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator...
- Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions.
You likely can't join if
- Current participation in another clinical trial involving investigational therapy, or participation in any other medical study considered...
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. History of uncontrolled seizures or central nervous system disease...
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention within 2 weeks prior...
- Myocardial infarction within 6 months prior to first dosing; uncontrolled arrhythmia (QTc ≥470 ms, calculated using Fridericia's formula); New York...
- Dysphagia, active gastrointestinal disease, history of major gastrointestinal surgery, malabsorption syndrome, or any condition that may affect...
- Active hepatitis B infection [HBsAg-positive with detectable HBV-DNA], active hepatitis C infection [HCV antibody-positive with detectable HCV-RNA]...
See the full eligibility criteria
- people voluntarily agree to participate in the study, fully understand the study procedures, provide written informed consent (ICF), and are willing and able to comply with all study procedures.
- Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage or locally advanced invasive breast cancer.
- Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
- Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator assessment.
- Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Ability to swallow capsules.
- Adequate bone marrow and organ function, defined as follows:
- Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; Hemoglobin ≥100 g/L (without red blood cell transfusion within 14 days prior to randomization); Platelet count ≥100 × 10\^9/L; Total serum bilirubin ≤1.5 × upper limit of...
- Current participation in another clinical trial involving investigational therapy, or participation in any other medical study considered scientifically or medically incompatible with this study.
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. History of uncontrolled seizures or central nervous system disease. History of other malignancies within the past 5 years. Pregnant or...
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention within 2 weeks prior to first dosing.
- Myocardial infarction within 6 months prior to first dosing; uncontrolled arrhythmia (QTc ≥470 ms, calculated using Fridericia's formula); New York Heart Association (NYHA) class III-IV heart failure; LVEF \<50%; or...
- Dysphagia, active gastrointestinal disease, history of major gastrointestinal surgery, malabsorption syndrome, or any condition that may affect absorption of study drugs.
- Active hepatitis B infection [HBsAg-positive with detectable HBV-DNA], active hepatitis C infection [HCV antibody-positive with detectable HCV-RNA], positive syphilis screening (except confirmed inactive infection)...
- Receipt of major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody-based antitumor therapy, or other systemic antitumor therapies considered by the investigator to interfere with study treatment how well...
- Planned or previous organ transplantation or bone marrow transplantation. Known history of psychiatric substance abuse or drug addiction. Any other condition that, in the investigator's judgment, would make the subject...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.