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Triple-positive breast cancer (TPBC) is a special type of breast cancer expressed by hormone receptor (HR) positive (HR+) and human epidermal growth factor receptor (HER2) positive (HER2+), with unique biological and clinical features, and sensitivity
to chemotherapy, targeted therapy and endocrine therapy.
Because it is affected by the interaction between HR signaling pathway and HER2 signaling pathway, there are still some difficulties
in the selection of treatment strategies for TPBC.
Professor Wang Haibo from the Breast Disease Hospital of the Affiliated Hospital of Qingdao University was honored to be the host, and Professor Wang Xiaojia from the Affiliated Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Cancer Hospital and Professor Chen Yiding from the Second Affiliated Hospital of Zhejiang University School of Medicine as the discussion guests.
Let's talk about TPBC treatment experience and the latest research progress
.
Q1: HR and HER2 are two important biological indicators affecting the prognosis of breast cancer patients, and triple-positive (HR+/HER2+) breast cancer is affected by both HR signaling pathway and HER2 signaling pathway.
The two signal paths of TPBC, HR and HER2, interfere with
each other.
Theoretically, HR+ breast cancer will be more sensitive to endocrine therapy, but due to the influence of HER2 pathway, its sensitivity will decrease.
Similarly, the HR pathway interferes with HER2-targeted therapies, which in turn affects the efficacy
of HER2-targeted therapies.
The overall prognosis of TPBC is better than that of HER2+ breast cancer, although the pathological complete response (pCR) rate of patients receiving targeted therapy combined with chemotherapy is 10%~15% lower than that of HER2+ breast cancer in neoadjuvant therapy, but in patients with advanced breast cancer, TPBC has a relatively long
survival.
The properties of TPBC bring important changes
to prognostic judgments, clinical decisions, and maintenance treatment decisions.
For the rescue treatment of TPBC, chemotherapy combined with targeted therapy is the main treatment strategy
in principle.
The results of Professor Yuan's SYSUCC-002 study1 pointed out that the efficacy of trastuzumab combined with endocrine therapy for TPBC is similar to that of trastuzumab combined with chemotherapy, and the toxicity is lower
.
This similar result may be due to the presence of ER pathways and the transformation of the disease into the Luminal type by targeted therapies, which is more sensitive
to endocrine therapy.
When the tumor progresses rapidly and the load is high, chemotherapy combined with targeted therapy is the main treatment strategy.
In the maintenance phase, targeted therapy combined with endocrine therapy is more
effective.
Therefore, TPBC should be treated individually, taking into account
factors such as the patient's specific type, tumor burden, previous survival, presence of visceral metastases, expected growth rate of the tumor, and sensitivity to treatment.
In general, we believe that the primary rescue therapy for TPBC is mainly targeted combination chemotherapy, and maintenance therapy is mainly based on targeted combination with endocrine therapy as a better choice
.
Professor Wang Xiaojia said that for the treatment of TPBC, the treatment plan should be selected based on clinicopathological characteristics, in general, anti-HER2 therapy is the main line, targeted therapy combined with chemotherapy is the main treatment strategy, and targeted therapy combined with endocrine therapy
can be considered in the maintenance treatment stage.
May I ask Professor Chen Yiding, in your clinical practice, what are the main relevant factors for the treatment of TPBC? How do I make a treatment decision?
The proportion of patients with TPBC is low, with HER2+ breast cancer accounting for about 20% of breast cancer, of which TPBC accounts for about half of HER2+ breast cancer, that is, about
10% of all breast cancers.
TPBC, as a special molecular subtype, has a high mutation rate of PIK3CA and a low mutation rate of TP53, so the treatment mode of TPBC is different from HER2+ breast cancer2
.
The interaction between the ER pathway and the HER2 signaling pathway makes TPBCs resistant to anti-HER2-targeted therapy or endocrine therapy
.
For the treatment of TPBC, anti-HER2 therapy is very important
.
Previous studies have shown that TPBC without anti-HER2 therapy has a higher risk of recurrence within 5 years than HER2+ (HR-/HER2+) breast cancer alone3
.
For neoadjuvant therapy for TPBC, pCR rates are lower4 and the association of pCR with event-free survival (EFS) is weaker than in patients with pure HER2-positive breast cancer5
.
In particular, the NeoALTTO study showed a very weak correlation between pCR and overall survival (OS) after neoadjuvant therapy for TPBC6
.
In addition, the HERA study suggests that the HER2 FISH ratio and mean HER2 copy number distribution are different in different ER states7
.
It can be seen from the above that TPBC, as a special disease type, should pay attention to the problem
of drug resistance in treatment.
Q2: The unique pathological characteristics of HR+/HER2+ breast cancer make its treatment have certain particularities, and how to choose the appropriate treatment plan according to the patient's situation in clinical practice is one of
the clinical concerns.
Based on your clinical experience, what experience do you have in HR+/HER2+ breast cancer treatment strategy selection?
The special mechanism of TPBC leads to the emergence of drug resistance during the use of different treatment regimens
.
TPBC is mainly treated with anti-HER2 therapy, combined with chemotherapy and endocrine therapy
.
In the clinical subdivision, Professor Chen Yiding, as an expert in breast surgery, what are the considerations in the choice of neoadjuvant therapy and adjuvant therapy?
From studies such as NeoALTTO, NeoSphere and TRYPHAENA, the pCR rate of TPBC neoadjuvant therapy is lower than that of pure HER2+ breast cancer people8, so many domestic clinical trials will avoid TPBC people
in the process.
However, both HR+ and HR- patients can benefit from dututurate bitarget therapy9
.
Whether it is neoadjuvant, adjuvant, or advanced, the treatment of TPBC is still based on anti-HER2 therapy
.
However, whether tyrosine kinase inhibitor (TKI) drugs can be combined on the basis of dual targets can make TPBC have better benefits, and some domestic studies are also being explored
.
Professor Liu Caigang conducted the MUKDEN 01 study of endocrine therapy combined with targeted therapy for TPBC, and found that the pCR rate was similar to that of traditional dual-target regimens10
.
Therefore, in the future TPBC treatment, it is very important
to overcome the interaction between ER signaling pathway and HER2 signaling pathway, and arrange the drug array to maximize the effect of drug combination.
Fig.
1 Efficacy of trastuzumab in patients with HR+ and HR-breast cancer9
For TPBC, late treatment has more intervention factors and needs to be selected
in combination with clinical trials.
Professor Wang Xiaojia, what do you think should be paid attention to in the treatment of advanced TPBC?
The recurrence of TPBC is related to many factors, such as the stage of the tumor, whether adjuvant therapy is standardized, and the efficacy of maintenance therapy
.
Therefore, the patient's condition should be evaluated
in clinical treatment.
The assessment mainly includes: (1) the situation of early adjuvant therapy, such as how long the patient's disease-free survival (DFS) is; (2) characteristics of tumor recurrence and metastasis; (3) Reconfirmation of molecular typing of metastases, whether there is heterogeneity, etc
.
These are all related to prognosis and choice of late-stage agent, and if TPBC is confirmed, treatment options are diverse, such as targeted therapy, chemotherapy, endocrine therapy, or combination therapy
.
For patients with longer DFS, small tumor burden, high hormone receptor expression level, and older age, chemotherapy can be used as much as possible during treatment, and targeted therapy combined with endocrine therapy
can be selected.
It can also be seen from Professor Yuan's SYSUCC-002 study1 that such patients have a relatively long
progression-free survival (PFS).
For young, high-burden patients, visceral metastases, and short DFS, chemotherapy in combination with standard targeted therapy should be considered, and a dutu dual-target combination chemotherapy regimen
should be prioritized in selection.
TKIs
may also be considered when patients have brain metastases.
In addition, there is a need to detect mutations in the pathway, because mutations can reduce the efficacy of endocrine therapy or targeted therapy, and the appropriate drug
can be selected for the genetic mutation after the mutation occurs.
Professor Wang Xiaojia said that after TPBC metastases recur, it is very important
to biopsy the metastases.
We can perform genetic testing on patients to see if there are changes in
other pathways.
Based on this, let's listen to Professor Chen Yiding's views on genetic testing.
Based on the characteristics of TPBC dual signal pathway interaction, high PIK3CA mutation rate and low TP53 mutation rate, it is necessary
for advanced patients to perform next-generation sequencing gene detection of large panels as soon as possible.
Genetic testing can determine whether patients have HER2 mutations, high copy numbers, PIK3CA mutations and ESR1 mutations, and help determine drug drug resistance, thereby transforming the treatment of
TPBC patients 。 In previous clinical practice, when TPBC patients had poor anti-HER2 treatment effect, they would be replaced with other anti-HER2 therapy, and other endocrine therapy drugs would be changed when the effect of endocrine therapy was poor, but after genetic testing, new targeted drugs could be added as needed in treatment decisions, so as to avoid frequent replacement of anti-HER2 therapy or endocrine therapy regimens, which is possible in future clinical treatment
.
Q3: HR+/HER2+ breast cancer patients are still mainly anti-HER2 therapy, in recent years, anti-HER2 therapy has developed rapidly, please talk about what new progress has been made in targeted therapy and endocrine therapy in recent years and the impact of these advances on HR+/HER2+ breast cancer treatment?
Professor Wang Haibo
In recent years, breast cancer drugs have developed rapidly, CDK4/6 inhibitors, tropa dual target applications, TKI drugs, the emergence of T-DM1, and antibody conjugate drugs (ADCs) have been successively applied to clinical practice
.
TPBC as a special type of breast cancer, can the above drugs simply perform 1+1, and will the effect of 1+1 be greater than 2?
The early and first-line treatment of TPBC is mainly anti-HER2 therapy, and for the latter-line treatment, the situation is more complicated, at this time, after neoadjuvant, adjuvant and first-line therapy, genetic mutations and abundance will change
。 Taking HR+ breast cancer as an example, the first-line treatment is dominated by ESR1 mutations, and there are some PIK3CA mutations and AKT mutations, but after the patient receives CDK4/6 inhibitor treatment, the signaling pathway will become more complex, and even close to 8~10 pathways or gene mutations will occur, so the treatment of such patients becomes more difficult, and the pathway that can make the patient have obvious benefits can not be found, and the patient's PFS will decline
.
MAINTAIN STUDY 11 at this year's ASCO conference showed that the effectiveness decreased significantly after switching to CDK4/6 inhibitors, only 6~8 months
.
The same is true for TPBC, the two pathways of HR and HER2, and the mutations of these two pathways bring challenges to the formulation of clinical strategies, but after detection, it is found that the mutations are mainly in one pathway, and second-line treatment can give priority to targeted drugs for this pathway, such as T-DM1 and small molecule TKI
.
ADC drugs I think are the main choice because they can ignore mutations
in other pathways.
Subsequent treatment of ADC can be considered genetic testing to see if there is a suitable drug to combine with targeted therapy
.
But the most important principle remains that anti-HER2 therapy will always be the main line
.
Triage therapy is very important
in the treatment of TPBC.
In the case of the MonarcHER study12, the results of this study were not ideal, possibly due to
the broad enrolment population.
Classified therapy is the choice of treatment according to different mutations, such as the addition of drugs for the PI3K pathway combined with anti-HER2 therapy drugs combined with chemotherapy or endocrine therapy.
Endocrine therapy can be upgraded to oral SERD, or a properly dual-target subcutaneous formulation (PH FDC SC) plus a targeted drug, and a dual-target subcutaneous formulation plus a targeted drug is only two targets, which can bring new options
for the treatment of TPBC.
In general, the treatment of TPBC is more complex, and the biological behavior of different mutations is also different, so it will rely on the combination of precision medicine, new drug development, drug accessibility, and patient willingness to comprehensively measure treatment strategies
.
Nowadays, we have new oral SERD drugs in HR+ breast cancer, and tripaz double-target subcutaneous preparations in anti-HER2 therapy, and the emergence of different dosage forms has greatly improved the convenience of clinical treatment and greatly improved
patient compliance.
Can you talk about the changes that the new drug dosage forms and administration methods will bring to the treatment of TPBC?
The development of new drugs is in full swing, and there are now four or five oral SEDs in development
.
For example, in the ADAPT HER2+/HR+ study13, the efficacy of T-DM1 + endocrine therapy was compared with T-DM1 monotherapy or trastuzumab + endocrine therapy, and the results found that T-DM1+ compared with single-agent T-DM1 Endocrine therapy did not significantly increase the rate of pCR and was independent of menopausal status
.
Therefore, the treatment of TPBC is still based on anti-HER2 therapy as the standard of care
.
In the past, complete estrogen deprivation could not be achieved with endocrine therapy, so the emergence of new oral SERD drugs is expected to maximize the antagonism of ER.
HeredERA study14 combined the novel oral SERD drug giredestrant with PH FDC SC for advanced TPBC, and subsequent positive results would be a major change
in TPBC treatment.
In an endocrine therapy combination with targeted therapy, the choice of endocrine therapy intensification regimen needs to consider whether the ER can be completely antagonized and lead to more beneficial outcomes
.
Today, the treatment of TPBC has moved towards the road of "going to chemotherapy", and it is worth looking forward to
whether it can go further on this road in the future and improve the quality of life of patients.
Q4: Research is endless, exploration is endless
.
Based on your clinical experience, please talk about what else is worth improving in the treatment of HR+/HER2+ breast cancer, what are the future development trends and breakthrough directions, and what are your expectations?
Professor Wang Xiaojia
Genetic mutations are common to TPBC and mean a variety
of treatment options.
TPBC has more pathways, and the more comprehensive the inhibition of the pathway, the more likely the patient is to reduce chemotherapy, so the selection of treatment according to Biomarker is very helpful
for clinical practice.
You can find more drugs from the direction of ER pathway to combine targeting, and even drugs from multiple pathways are combined with each other, which may be more conducive to chemotherapy regimens
.
In addition, the development of new drugs such as PH FDC SC, oral SERD giredestrant, and PI3K inhibitor Inavolisib will bring a variety of options to breast cancer patients, such as I am leading a study to observe the efficacy of inavolisib combined with a dual-target subcutaneous preparation in patients with HER2+/PIK3CA mutations in advanced breast cancer, which will also provide opportunities for multipathway inhibition in TPBC patients with PIK3CA mutations
。 It is also expected to bring different therapies to TPBC patients, while reducing the possibility of chemotherapy, avoiding the impact of chemotherapy on the quality of life of patients, enabling patients to preserve their physical status, creating conditions for more treatment opportunities, and improving prognosis
.
I think there are several trends in the future:
(1) Research on accurate classification of breast cancer: including HER2+, triple negative, HR+/HER2- and HR+/HER2+, etc.
, I-SPY2 study in the ASCO conference some time ago15, reflects the classification based on the response to neoadjuvant therapy, which helps us to study the classification of triple-positive breast cancer more thoroughly
.
(2) The possibility of chemotherapy: trastuzumab ± pertuzumab + aromatase inhibitor (AI) in the first-line treatment of advanced patients is being studied, if patients can benefit from dual-target + AI, they may not need chemotherapy, which is of great significance
for clinical treatment.
(3) TPBC treatment structure changes: the extension of PFS in triple-positive patients has been prolonged from endocrine therapy combined with lapatinib to endocrine therapy + lapatinib combined with trastuzumab, and now it has developed to endocrine therapy combined with double target, or endocrine therapy combined with dual target combined with CDK4/6 inhibitors, and the PFS of patients is constantly prolonged
.
These are all really beneficial to the three positive patients
.
It is hoped that in the future, endocrine combined targeted therapy can dominate the treatment of early or advanced triple-positive patients
.
Thanks to the two professors for sharing today, TPBC, as a special group, must take into account the particularity of
dual pathways in treatment.
Anti-HER2 therapy is the main strategy of TPBC, and today new drugs are constantly evolving, providing us with more treatment combinations
.
Precision treatment can bring a basis for the formulation of clinical strategies, make it possible to go to chemotherapy, and reduce the toxic side effects in the treatment process of patients, which is not only our clinical expectations, but also the direction of
future research.
(Click to view the full video of this issue of the celebrity club)
Expert profiles
Professor Wang Haibo
Dean of the Breast Disease Hospital of the Affiliated Hospital of Qingdao University, doctoral supervisor
Dean of the Institute of Clinical Translational of Solid Oncology, Qingdao University
Vice Chairman of the Breast Cancer Expert Committee of the Chinese Society of Clinical Oncology
Member of the Standing Committee of the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association
Standing Committee Member of Breast Professional Training Expert Committee of Chinese Medical Doctor Association
Vice Chairman of the Breast Branch of the Minimally Noninvasive Committee of the Chinese Medical Doctor Association
Standing Committee Member of Breast Disease Branch of China Medical Education Association
Standing Committee Member of Breast Plastic Surgery Branch of Chinese Association for the Promotion of Medicine
Chairman of the Breast Disease Branch of Shandong Rehabilitation Medical Association
He is the chairman-elect of the Breast Branch of Shandong Clinical Oncology Association
Vice Chairman of the Breast Multidisciplinary Cooperation Branch of Shandong Medical Association
Professor Wang Xiaojia
Assistant to the President of the Affiliated Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Provincial Cancer Hospital
Director of Department of Breast Medicine, Chief Physician (Second Level), Ph.
D.
, Doctoral Student and Postdoctoral SupervisorDeputy Director of Zhejiang Cancer Intelligent Diagnosis and Molecular Technology Research Center
Vice Chairman of the Breast Cancer Expert Committee of the Chinese Society of Clinical Oncology
Member of the Standing Committee of the Breast Cancer Professional Committee and the Standing Committee of the Medical Ethics Committee of the Chinese Anti-Cancer Association
Member of the Oncology Cardiology Group of the Cardiovascular Disease Branch of the Chinese Medical Association
Vice President of Yangtze River Delta Cancer Specialist Alliance
Chairman of Zhejiang Breast Cancer Quality Control Expert Committee
Chairman of the Medical Oncology Branch of Zhejiang Medical Association and Vice Chairman of the Pain Branch
Chairman of the Breast Cancer Professional Committee of Zhejiang Anti-Cancer Association and former chairman of the Medical Oncology Committee
Vice President of Zhejiang Society of Immunology (Former Chairman of the Professional Committee of Tumor Immunology and Biotherapy)
Vice President of Zhejiang Translational Medicine Association and President of Precision Medicine Branch
Professor Chen Yiding
Chief physician, director of the Department of Breast Surgery, and doctoral supervisor of the Second Affiliated Hospital of Zhejiang University School of Medicine
Member of the Standing Committee of the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association
Member of the Standing Committee of Family Hereditary Tumor Special Committee of Chinese Anti-Cancer Association
Standing Committee Member of Breast Disease Branch of China Association for the Promotion of Medical Care
He is the chairman-elect of the Breast Cancer Professional Committee of Zhejiang Anti-Cancer Association
Member of Surgical Oncology Branch and Oncology Branch of Zhejiang Medical Association
As the person in charge, he has been funded by the National Natural Science Foundation of China and provincial and ministerial projects for 5 projects
As a major participant, he won 2 provincial and ministerial scientific and technological achievement awards
As the first inventor, he has obtained 2 national invention patents and published nearly 36 papers, including 17 journal papers included in SCI
So far, 13 master's students and 3 doctoral students have been trained
References:
1.
Zhongyu Yuan, Jia-Jia Huang, Xin Hua,et al.
Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for metastatic breast cancer with hormone receptor-positive and HER2-positive: The sysucc-002 randomized clinical trial.
2021 ASCO Annual Meeting.
Abstract 1003.
2.
Brandão M, Caparica R, Malorni L,et al.
What Is the Real Impact of Estrogen Receptor Status on the Prognosis and Treatment of HER2-Positive Early Breast Cancer? Clin Cancer Res.
2020 Jun 15; 26(12):2783-2788.
3.
Strasser-Weippl K, Horick N, Smith IE, et al.
Long-term hazard of recurrence in HER2+ breast cancer patients untreated with anti-HER2 therapy.
Breast Cancer Res.
2015 Apr 16; 17(1):56.
4.
Nahta R, O'Regan RM.
Therapeutic implications of estrogen receptor signaling in HER2-positive breast cancers.
Breast Cancer Res Treat.
2012 Aug; 135(1):39-48.
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Cortazar P, Zhang L, Untch M, et al.
Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.
Lancet.
2014 Jul 12; 384(9938):164-72.
6.
de Azambuja E, Holmes AP, Piccart-Gebhart M, et al.
Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response.
Lancet Oncol.
2014 Sep; 15(10):1137-46.
7.
Loi S, Dafni U, Karlis D, et al.
Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial.
JAMA Oncol.
2016 Aug 1; 2(8):1040-7.
8.
Nahta R, O'Regan RM.
Therapeutic implications of estrogen receptor signaling in HER2-positive breast cancers.
Breast Cancer Res Treat.
2012 Aug; 135(1):39-48.
9.
Chumsri S, Li Z, Serie DJ, et al.
Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31.
J Clin Oncol.
2019 Dec 10; 37(35):3425-3435.
10.
Niu N,Qiu F,Liu T,et al.
Primary analysis of MUKDEN 01: A multicenter, single-arm, prospective, phase 2 study of neoadjuvant treatment with pyrotinib and letrozole plus dalpiciclib in triple-positive breast cancer.
.
2022 ASCO.
Poster 588.
11.
Kevin Kalinsky, Melissa Kate Accordino, Codruta Chiuzan, et al.
A randomized, phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor–positive (HR+), HER2-negative metastatic breast cancer (MBC): MAINTAIN trial.
J Clin Oncol 40, 2022 (suppl 17; abstr LBA1004).
DOI: 10.
1200/JCO.
2022.
40.
17_suppl.
LBA1004.
12.
Tolaney SM，Wardley AM，Zambelli S，et al． Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptorpositive，HEＲ2－positive advanced breast cancer ( monarcHEＲ) :a randomised，open-label，phase 2 trial［J］． Lancet Oncol，2020，21( 6) : 763-775．
13.
Harbeck N, Gluz O, Christgen M,et al.
De-Escalation Strategies in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (BC): Final Analysis of the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early BC HER2- and Hormone Receptor-Positive Phase II Randomized Trial-Efficacy, Safety, and Predictive Markers for 12 Weeks of Neoadjuvant Trastuzumab Emtansine With or Without Endocrine Therapy (ET) Versus Trastuzumab Plus ET.
J Clin Oncol.
2017 Sep 10; 35(26):3046-3054.
14.
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer).
https://clinicaltrials.
gov/ct2/show/NCT05296798?term=NCT05296798&draw=2&rank=1
15.
Laura Ann Huppert,et al.
Pathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial.
2022 ASCO, Poster 504.
Editor: Bingxin
Review: Bingxin
Typesetting: Youshi
Execution: Small garden
#Celebrity meeting room | big coffee face to face, from the drug safety to see the "way of using soldiers" of breast cancer ADC drugs
