Hormone Receptor-Positive Breast Cancer: New Advances from SABCS

Groundbreaking research presented at the 2024 San Antonio Breast Cancer Symposium is reshaping treatment paradigms for the most common form of breast cancer.

Oral SERDs ESR1 Mutations Combination Therapy Precision Medicine

The Evolving Battle Against HR+ Breast Cancer

For the millions of people living with hormone receptor-positive (HR+) breast cancer, treatment has long revolved around a simple principle: block estrogen's ability to fuel cancer growth. This approach has saved countless lives, but it has limitations. Many cancers eventually develop resistance to traditional therapies, creating a critical need for more effective strategies.

At the latest San Antonio Breast Cancer Symposium (SABCS), researchers unveiled groundbreaking advances that are reshaping treatment paradigms for HR+ breast cancer. From powerful new oral medications that overcome treatment resistance to innovative approaches that help patients avoid unnecessary therapy, these developments offer new hope in the ongoing fight against the most common form of breast cancer.

70%

of all breast cancers are HR+

40-50%

develop ESR1 mutations after endocrine therapy

9.4

months PFS with imlunestrant + abemaciclib

The Changing Landscape of HR+ Breast Cancer Treatment

Hormone receptor-positive breast cancer, which accounts for approximately 70% of all breast cancers, grows in response to estrogen and/or progesterone. For decades, the standard treatment approach has involved endocrine therapy - medications that either block estrogen receptors or reduce estrogen production in the body. While drugs like tamoxifen and aromatase inhibitors have been cornerstone treatments, the emergence of resistance has remained a significant challenge, particularly in advanced cases.

ESR1 Mutations

Occur in the estrogen receptor gene itself, leading to constitutive activation of estrogen signaling even in the presence of traditional endocrine therapy.

PI3K/AKT/mTOR Pathway

Alterations in this pathway create another escape route for cancer cells to bypass treatment and develop resistance.

Treatment Evolution Timeline

Traditional Endocrine Therapy

Tamoxifen, aromatase inhibitors - block estrogen receptors or reduce estrogen production

First-Generation SERDs

Fulvestrant - requires monthly intramuscular injections

CDK4/6 Inhibitors

Palbociclib, abemaciclib, ribociclib - combined with endocrine therapy

Next-Generation Oral SERDs

Imlunestrant - oral medications that overcome resistance mechanisms

Breaking Through Resistance: Next-Generation Oral SERDs

One of the most exciting developments presented at SABCS was the emergence of next-generation oral Selective Estrogen Receptor Degraders (SERDs). These medications represent a significant advance over older endocrine therapies because they not only block estrogen receptors but also trigger their degradation, making it harder for cancer cells to develop resistance.

The EMBER-3 Trial: A Potential New Standard

The phase III EMBER-3 clinical trial took center stage at the symposium, evaluating the investigational oral SERD imlunestrant in patients with ER-positive, HER2-negative advanced breast cancer that had progressed on prior endocrine therapy.

Methodology

This multicenter study enrolled 874 patients whose cancer had recurred or progressed during or after treatment with an aromatase inhibitor alone or in combination with a CDK4/6 inhibitor. Participants were randomly assigned to one of three treatment groups:

  • Group 1: Imlunestrant alone
  • Group 2: Standard endocrine therapy (fulvestrant or exemestane) alone
  • Group 3: Imlunestrant plus abemaciclib (a CDK4/6 inhibitor)

Unlike the first-generation SERD fulvestrant, which requires monthly intramuscular injections, imlunestrant is an oral medication with the added advantage of being able to penetrate the blood-brain barrier, potentially offering protection against central nervous system metastases.

Results and Analysis

The findings, presented by Dr. Komal Jhaveri of Memorial Sloan Kettering Cancer Center, were practice-changing:

Treatment Group Progression-Free Survival (Overall) Progression-Free Survival (ESR1-Mutant) Risk Reduction vs. Standard Therapy
Imlunestrant alone Not significantly improved Significantly improved 38% in ESR1-mutant patients
Imlunestrant + abemaciclib 9.4 months Benefit observed regardless of ESR1 status 43% vs. imlunestrant alone
Standard endocrine therapy 5.5 months Less effective in ESR1-mutant patients Reference group

The trial demonstrated that imlunestrant significantly improved progression-free survival in patients with ESR1 mutations, reducing the risk of progression or death by 38% compared to standard endocrine therapy. This is particularly significant given that ESR1 mutations occur in 40-50% of patients whose cancer progresses on endocrine therapy.

Perhaps even more impressive were the results from the combination arm: imlunestrant plus abemaciclib reduced the risk of progression or death by 43% compared to imlunestrant alone, with benefits seen in all patient subgroups regardless of ESR1 or PI3K pathway mutation status.

Treatment Most Common Adverse Events Discontinuation Rate Patient-Reported Injection Site Issues
Imlunestrant monotherapy Generally low-grade, manageable Low Not applicable (oral medication)
Imlunestrant + abemaciclib Consistent with known abemaciclib profile 6.3% Not applicable (oral medication)
Standard therapy (fulvestrant) Typical for endocrine therapy Comparable to other regimens 72% reported pain, swelling, or redness

The safety profile was favorable, with generally low-grade and manageable adverse events. Importantly, as an oral medication, imlunestrant avoids the injection site pain, swelling, and redness reported by 72% of patients receiving fulvestrant.

Key Advantages of Oral SERDs
  • Oral administration improves patient convenience and adherence
  • Ability to penetrate blood-brain barrier may protect against CNS metastases
  • Effective against ESR1-mutant cancers resistant to traditional therapies
  • Favorable safety profile with manageable side effects
  • No injection site reactions compared to fulvestrant

Additional Groundbreaking Research from SABCS

Beyond the EMBER-3 trial, several other studies presented at the symposium are reshaping HR+ breast cancer treatment:

PATINA Trial

Evaluated adding palbociclib (Ibrance) to standard first-line treatment for metastatic triple-positive breast cancer (HR+/HER2+). Results showed the addition improved progression-free survival by more than 15 months compared to standard therapy alone 1 .

DESTINY-Breast06

Updated results confirmed that Enhertu (T-DXd) is more effective than chemotherapy for patients with metastatic HR+ breast cancer that is HER2-low or HER2-ultralow and has progressed on endocrine therapy 1 .

OlympiA Trial

With a median follow-up of 6.1 years, continued to show that adjuvant olaparib (Lynparza) improves survival by 35% compared to placebo in patients with BRCA-mutated, high-risk, HER2-negative early breast cancer 1 .

Treatment Benefit Comparison

PATINA Trial: PFS Improvement

+15 months with palbociclib combination

OlympiA Trial: Survival Improvement

35% survival improvement with olaparib

EMBER-3: Risk Reduction (ESR1-mutant)

38% risk reduction with imlunestrant

EMBER-3: Risk Reduction (Combination)

43% risk reduction with imlunestrant + abemaciclib

The Scientist's Toolkit: Key Biomarkers and Research Reagents

Modern HR+ breast cancer research relies on sophisticated biomarkers and reagents that enable precision medicine approaches:

Tool/Biomarker Function/Application Clinical Significance
ESR1 Mutation Testing Identifies mutations in estrogen receptor gene Predicts response to oral SERDs; detected in 40-50% of endocrine-resistant cases
Liquid Biopsy/ctDNA Detects tumor DNA in blood samples Monitors treatment response and emergence of resistance mutations
Next-Generation Sequencing (NGS) Comprehensive genomic profiling Identifies multiple potential therapeutic targets simultaneously
PD-L1 Staining Measures immune checkpoint protein expression Guides immunotherapy use in aggressive subtypes
PIK3CA Mutation Testing Identifies mutations in PI3K pathway Predicts response to PI3K inhibitors like inavolisib
BRCA Germline Testing Detects inherited BRCA1/2 mutations Identifies patients who may benefit from PARP inhibitors like olaparib
Biomarker Utilization in Clinical Practice

These tools have become increasingly important as research moves beyond traditional histologic classification toward molecular subtyping and resistance mechanism identification.

ESR1 Mutation Testing 85%
NGS Panels 70%
Liquid Biopsy 55%
Molecular Subtypes in HR+ Breast Cancer

Understanding the molecular diversity within HR+ breast cancer is crucial for treatment personalization.

Luminal A 40%
Luminal B 30%
Other subtypes 30%

Conclusion: A Promising Future for HR+ Breast Cancer

The developments unveiled at the San Antonio Breast Cancer Symposium represent significant strides in the management of hormone receptor-positive breast cancer. The emergence of effective oral SERDs like imlunestrant, the strategic combination therapies that overcome resistance mechanisms, and the refined understanding of biomarker-driven treatment selection all point toward a more hopeful future for patients.

"We need much more education on understanding genomics and treating endocrine-resistant breast cancer based on biomarkers"

Dr. Aditya Bardia, prominent researcher in the field 6

This sentiment captures the evolving nature of HR+ breast cancer care - one that increasingly prioritizes molecular understanding and personalized treatment approaches over blanket strategies.

While challenges remain, particularly in managing treatment sequencing and addressing diverse resistance mechanisms, the progress highlighted at SABCS 2024 provides tangible hope that HR+ breast cancer is becoming a more manageable condition, even in its advanced stages. As these new therapies continue through development and regulatory approval, they promise to transform the standard of care and offer patients more effective, tolerable, and convenient treatment options.

More Treatment Options

Oral SERDs and targeted combinations expand therapeutic arsenal

Personalized Approach

Biomarker-driven treatment selection improves outcomes

Improved Quality of Life

Oral medications and better side effect profiles enhance patient experience

References