Related Experiment Video
Updated: Jun 3, 2026
03:07
Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Fovinaciclib for First-Line Therapy of Advanced Breast Cancer: A Randomized Clinical Trial.
Peng Yuan1, Yunjiang Liu2, Wei Li3
1Department of Medical Oncology, Chinese Academy of Medical Sciences Cancer Hospital, Beijing, China.
JAMA Oncology
|June 1, 2026
Summary
Adding fovinaciclib to aromatase inhibitor significantly improved progression-free survival in patients with hormone receptor-positive advanced breast cancer. The combination therapy demonstrated manageable safety and maintained quality of life.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (BC) accounts for approximately 70% of BC cases.
- Effective first-line treatment options are crucial for improving patient outcomes in this common subtype of breast cancer.
Purpose of the Study:
- To evaluate the efficacy and safety of fovinaciclib combined with an aromatase inhibitor as a first-line treatment for advanced hormone receptor-positive, ERBB2-negative breast cancer.
- To assess the impact of this combination therapy on progression-free survival, overall survival, and quality of life.
Main Methods:
- A double-blind, phase 3 randomized clinical trial involving 417 adult female patients in China.
- Patients received either fovinaciclib (200 mg daily) or placebo, both in combination with letrozole or anastrozole, in 28-day cycles.
- The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review.
Main Results:
- Fovinaciclib significantly prolonged median progression-free survival compared to placebo (not reached vs. 20.2 months; hazard ratio, 0.55; P < .001).
- Consistent PFS benefits were observed across most patient subgroups, and fovinaciclib showed advantages in secondary efficacy endpoints.
- Treatment-emergent adverse events were primarily hematologic, with low rates of serious events or discontinuation (1.4% in both arms). Quality of life remained similar between groups.
Conclusions:
- First-line treatment with fovinaciclib plus an aromatase inhibitor offers significant and clinically meaningful progression-free survival benefits for patients with advanced hormone receptor-positive, ERBB2-negative breast cancer.
- The combination therapy is associated with manageable safety profiles and does not negatively impact quality of life.
- This regimen represents a promising new therapeutic option for this patient population.
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
02:56Treatment Resistent Cancers
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
02:56Treatment Resistant Cancers
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
02:57Targeted Cancer Therapies
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
There are several types of targeted therapies against specific...
02:57Targeted Cancer Therapies
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
There are several types of targeted therapies against specific...