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Hr+/her2- Metastatic Breast Cancer

Ribociclib And Overall Survival By Intrinsic Tumor Subtype

NCCN Guidelines for HR HER2 Metastatic Breast Cancer

Lisa A. Carey, M.D., of the University of North Carolina at Chapel Hill, presented results from an analysis of overall survival in the MONALEESA-2, -3, and -7 trials by intrinsic tumor subtype.

In the retrospective exploratory analysis, tumor samples from patients in the MONALEESA trials underwent gene expression profiling with the Prediction Analysis of Microarray 50 assay. Luminal A was the most common subtype , followed by luminal B , HER2-enriched , and basal-like .

Across all patients, ribociclib added to ET significantly improved OS by 25% compared with ET alone . However, results showed a significant interaction between tumor subtype and survival benefit . Ribociclib significantly improved OS for patients with luminal A , luminal B , and HER2-enriched tumor subtypes . In contrast, ribociclib did not improve OS relative to placebo in patients with basal-like tumors .

Intrinsic tumor subtype was prognostic for survival outcomes after adjusting for clinical covariates. Patients with the basal-like subtype did not appear to benefit from CDK 4/6 inhibitor therapy, whereas those with HER2-enriched tumors experienced the greatest magnitude of survival benefit.

The phase III HARMONIA trial will evaluate the activity of ribociclib plus ET in patients with HER2-enriched tumors, with the goal of providing further insight on developing personalized treatment plans for patients with HR+/HER2 metastatic breast cancer.

Metastatic Distribution Patterns Of First Metastatic Sites

The first metastatic sites were classified into single metastases or multiple metastases. Single metastases were further classified into diffuse or non-diffuse lesions. Non-diffuse lesions were defined as localized or focal lesions in a single metastatic organ or site regardless of size, whereas diffuse lesions were defined as multiple lesions widely spreading in a single metastatic organ or site. Non-diffuse lesions included a solitary metastatic lesion in one single organ , the involvement of a single lymphatic site , or a solitary or isolated metastatic bone lesion. On the other hand, diffuse lesions included multiple lesions in one single organ , the involvement of two or more lymphatic sites , multiple metastatic bone lesions, or pleural or peritoneal dissemination.

New Novartis Data Show Piqray Effectiveness Across Key Biomarkers In Patients With Hr+/her2

  • Biomarker analysis from Phase III SOLAR-1 study shows Piqray plus fulvestrant had clinical benefit regardless of presence of ESR1 mutations and genes implicated in CDK4/6i resistance1
  • Piqray plus fulvestrant efficacy persists even with prior fulvestrant treatment importance of targeting the PIK3CA driver mutation highlighted, as presented in a retrospective analysis of real-world evidence2
  • Piqray is the only treatment specifically approved for HR+/HER2- mBC with a PIK3CA mutation, a key oncogenic driver of the disease3-5

Basel, June 3, 2022 Novartis today announced results of an exploratory retrospective biomarker analysis finding that different genetic mutation profiles in tumors harboring PIK3CA mutation did not affect treatment benefit with Piqray® plus fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. Selected as an oral presentation at the 2022 American Society of Clinical Oncology Annual Meeting , the retrospective analysis of data from the Phase III SOLAR-1 study found that the clinical benefit of the Piqray and fulvestrant combination was maintained regardless of genetic alterations in most biomarkers, including ESR1 and genes implicated in resistance to CDK4/6 inhibitors1.

Highlights from the SOLAR-1 biomarker retrospective analysis at ASCO


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    Cancer And The Female Breast

    Figure: Breast and Adjacent Lymph Nodes

    Figure: The female breast along with lymph nodes and vessels. An inset shows a close-up view of the breast with the following parts labeled: lobules, lobe, ducts, nipple, areola, and fat.

    Inside a woman’s breast are 15 to 20 sections, or lobes. Each lobe is made of many smaller sections called lobules. Fibrous tissue and fat fill the spaces between the lobules and ducts . Breast cancer occurs when cells in the breast grow out of control and form a growth or tumor. Tumors may be cancerous or not cancerous .

    Additional Information

    Kohler BA, Sherman RL, Howlader N, Jemal A, Ryerson AB, Henry KA, Boscoe FP, Cronin KA, Lake A, Noone AM, Henley SJ, Eheman CR, Anderson RN, Penberthy L. Annual Report to the Nation on the Status of Cancer, 1975-2011, Featuring Incidence of Breast Cancer Subtypes by Race/Ethnicity, Poverty, and State. J Natl Cancer Inst. 2015 Mar 30 107:djv048. doi: 10.1093/jnci/djv048. Print 2015 Jun.

    Systemic Treatments For Stage Iv Breast Cancer

    Patrick Murphy on LinkedIn: Exciting and promising times for ADCs and ...

    Treatment often continues until the cancer starts growing again or until side effects become unacceptable. If this happens, other drugs might be tried. The types of drugs used for stage IV breast cancer depend on the hormone receptor status, the HER2 status of the cancer, and sometimes gene mutations that might be found.

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    What Are The Side Effects Of Treatment

    Generally, the side effects of hormonal therapies tend to be mild and fairly well tolerated, says Brufsky. The most common side effects are menopausal symptoms , achiness in the joints and bones, and fatigue. AIs can cause some bone loss , but that can typically be well controlled with bone-modifying medications, Brufsky notes. CDK4/6 inhibitors may cause low white blood cell counts as well as some nausea and diarrhea.

    How Can I Tell If My Treatment Is Working

    One way youll know is if your pain starts going away, Brufsky says. Your doctor will also monitor your progress every few months with a variety of assessments, which may include a physical exam, blood tests to check for tumor markers, and imaging tests: X-ray, CT scan, PET scan, or bone scan. The results of these tests, combined with the symptoms you report, will help your cancer team understand whether your treatment is helping to control tumor growth, according to

    Treatment is typically continued if its working and your side effects are manageable, but if the treatment is no longer working or the side effects are problematic, your doctor may switch you to a different drug. We expect that just about every treatment we choose will work for a period of time and then likely stop working as the cancer develops resistance, Brufsky says. Fortunately, we have many treatments that are effective with HR-positive/HER-2-negative metastatic breast cancer.

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    Primary And Secondary Outcomes

    The primary outcome was PFS defined as the time from initiation of the first systemic therapy for metastatic disease to disease progression or death, whichever occurred first. Progression, as determined by the DATECAN initiative, was defined as progression of the initial metastases or the occurrence of new metastases.

    Our secondary outcome was OS, which was defined as the time from initiation of the first systemic anti-metastatic therapy to death.

    Women alive without progression were censored at the end of the study period .

    Evolving Treatment Landscape Of Hr+/her2

    Treatments for HR , HER2-Negative Metastatic Breast Cancer


    Massimo Cristofanilli, MD, FACS: Hormone receptor-positive metastatic breast cancer is the most common condition that we as medical oncologists deal with after the patient has a recurrence. As we know, the most common type of breast cancer is hormone receptor-positive disease, and these tumors tend to recur in a predictable way, particularly when they have high-risk conditions including node involvement, large size, and high recurrence score, in the bone, soft tissue, and sometimes in the organs. For these patients, traditionally the treatment has been single-agent androgen therapy. Originally, it was only tamoxifen subsequently, for postmenopausal women we had different aromatase inhibitors that showed improvement in the progression-free survival, but never showed an improvement in survival. Then Faslodex , one of the SERDs that was used in comparison with aromatase inhibitors in this specific setting, appeared to be superior, particularly in patients with bone disease.

    Transcript edited for clarity.

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    What To Look For In Your Pathology Report

    When you have a biopsy for a breast tumor, the pathology report tells you a lot more than whether its cancerous or not. It provides crucial information about the makeup of your tumor.

    This is important because some types of breast cancer are more aggressive than others, meaning they grow and spread faster. Targeted treatments are available for some types, but not for all.

    Each type of breast cancer requires its own approach to treatment. The information in your pathology report will help guide your treatment goals and options.

    Two important items on the report will be your HR status and your HER2 status.

    Continue reading to learn more about how HR and HER2 status in breast cancer affects your treatment and your outlook.

    Ethics Approval And Consent To Participate

    Patient consent is not required for observational studies. In addition, patients included in the registry are informed during their treatment that their data can be used for research purposes and they can then refuse to have all or part of their data used. As a cancer registry, the Côte dOr Breast and Gynaecological Cancer Registry has obtained the approval of the French national data protection authority for data recording, and this study was approved by the French national data protection authority

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    Hr+/her2 Metastatic Breast Cancer: Recent Advances

    Breast cancer patients have benefited from clear advances in treatment options during the past four decades. Expanding therapeutic options have reflected substantial improvements in clinical outcomes. The Oncologist prioritizes the publication of work that has clear clinical application, and the Editors are pleased to invite you to explore The Oncologist’s collection of original research and review articles on advances in the diagnosis and management of breast cancer. This collection covers diverse topics of interest to clinicians, but with a primary focus on current advances in HR+/HER2 metastatic breast cancer. The practical nature of this collection brings the state of the art in the treatment of breast cancer directly to the clinic to improve the care of your patients.

    Should I Enroll In A Clinical Trial

    Group 5E: HER2

    Clinical trials are definitely worth considering, according to the Susan G. Komen organization. They offer the chance to try and possibly benefit from new treatments. The best time to join a trial is before starting treatment or, if your provider is considering changing treatments, before you switch to a new treatment. Ask your doctor if there are any trials that would suit your circumstances. You can also search the clinical trial database at or use the Susan G. Komen Metastatic Trial Search, a personalized tool to match you with clinical trials.

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    How Is This Cancer Treated

    Your treatment plan will depend on where the cancer has spread, the extent of the disease, other medical conditions you have, and your age and menopause status. Common therapies include:

    • Ovarian suppression For premenopausal women with metastatic breast cancer of this type, hormone therapy almost always begins with ovarian suppression by means of surgery to remove the ovaries or drugs, such as goserelin or leuprolide, that stop the ovaries from producing hormones, says Brufsky. Ovarian suppression lowers hormone levels in the body so the tumor cant get the estrogen it needs to grow.
    • Aromatase inhibitors Postmenopausal women and premenopausal women who have undergone removal or suppression of their ovaries are often treated with AIs, such as anastrozole, exemestane, and letrozole. These drugs block the activity of the enzyme aromatase, which the body uses to make estrogen in the adrenal glands and fat tissue. This means less estrogen is available to stimulate the growth of HR-positive breast cancer cells, according to the National Cancer Institute.
    • CDK4/6 inhibitors These drugs, which include palbociclib, ribociclib, and abemaciclib, block proteins in the cell known as cyclin-dependent kinases . CDKs regulate cell proliferation and growth and are often elevated in breast cancer, fueling uncontrolled growth of cancer cells. They are typically used in combination with AIs as a first-line treatment for HR-positive/HER-2-negative metastatic breast cancer, Brufsky says.

    Where To Look For Symptoms Of Metastatic Breast Cancer

    When cancer spreads, there are key areas to look for symptoms. Where the cancer spreads will determine the symptoms patients may experience. Here are some common areas where breast cancer can spread.



    If you’ve recently been diagnosed with metastatic breast cancer, it’s important that your doctor test for an abnormal PIK3CA gene, as knowing whether or not you have this mutation can help inform your treatment.


    • who have hormone receptor -positive, human epidermal growth factor receptor 2 -negative advanced breast cancer or breast cancer that has spread to other parts of the body , with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha gene, and
    • whose disease has progressed on or after endocrine therapy

    Your health care provider will test your cancer for an abnormal “PIK3CA” gene to make sure that PIQRAY is right for you.

    It is not known if PIQRAY is safe and effective in children.

    Important Safety information

    Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.

    PIQRAY may cause serious side effects, including:

    Your health care provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with PIQRAY if you get certain serious side effects.

    Before you take PIQRAY, tell your health care provider about all of your medical conditions, including if you:


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    Will I Ever Be Cured

    Oncologists dont talk about curing stage 4 breast cancer as much as managing it as you would other chronic diseases, according to Brufsky. Were not likely going to get rid of every single bit of cancer, but were learning that people can live with this disease and be asymptomatic for years and years, he explains. While the mean survival of patients with HR-positive/HER-2-negative metastatic breast cancer is now over five years, its hard to say what the future holds for a woman diagnosed with the disease today. The field is changing so quickly and dramatically that in two or three years, this will be a different conversation.

    Taking Care Of Yourself

    Palbociclib Combined With Fulvestrant in Relapsed Metastatic HR /HER2- Breast Cancer

    It can be very stressful to have cancer. It can be easier to handle when you take care of your body and mind.

    There are different things that can help.

    Eat healthy and exercise. Make sure fruits and vegetables have a big role in your menu. Also:

    • Get plenty of exercise.
    • Cut back on alcohol.
    • Kick the habit if you smoke.

    Keep up with your doctor visits. Donât miss any appointments, and reach out to your doctor whenever you have questions.

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    Early Cdk4/6 Inhibitors Are Not Inferior To Chemotherapy In Hr+/her2

    This picture was taken during a previous ESMO congress

    Seemingly disappointing survival findings in the final results from the PEARL study are balanced by better quality of life with combination therapy

    CDK4/6 inhibitors plus endocrine therapy appear to be the preferred alternative to chemotherapy for early treatment of hormone receptor -positive, HER2-negative metastatic breast cancer progressing on aromatase inhibitors . Although no survival benefit was observed in the final results of the phase III PEARL study , combination therapy seems to provide quality of life and tolerability benefits over chemotherapy.

    Median OS times of 31.1 months were reported with palbociclib plus fulvestrant and 32.8 months with capecitabine at a median follow-up of 28.0 months. The results follow earlier findings from the trial showing no progression-free survival advantage for the combination over chemotherapy but an improved toxicity profile and a reduction in the time to deterioration of global health status.

    Figure. Overall survival at median follow-up of 28.0 months shows no significant difference for palbociclib + fulvestrant versus capecitabine

    Jimenez M. M. Overall Survival of palbociclib plus endocrine therapy versus capecitabine in hormone-receptor+/HER2- metastatic breast cancer that progressed on aromatase inhibitors . Final results of the PEARL study. ESMO Congress 2021, Abstract 229MO

    Local Or Regional Treatments For Stage Iv Breast Cancer

    Although systemic drugs are the main treatment for stage IV breast cancer, local and regional treatments such as surgery, radiation therapy, or regional chemotherapy are sometimes used as well. These can help treat breast cancer in a specific part of the body, but they are very unlikely to get rid of all of the cancer. These treatments are more likely to be used to help prevent or treat symptoms or complications from the cancer.

    Radiation therapy and/or surgery may also be used in certain situations, such as:

    • When the breast tumor is causing an open or painful wound in the breast
    • To treat a small number of metastases in a certain area, such as the brain
    • To help prevent or treat bone fractures
    • When a cancer is pressing on the spinal cord
    • To treat a blood vessel blockage in the liver
    • To provide relief of pain or other symptoms anywhere in the body

    In some cases, regional chemo may be useful as well.

    If your doctor recommends such local or regional treatments, it is important that you understand the goalwhether it is to try to cure the cancer or to prevent or treat symptoms.

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    Summary Of Treatment Options For Metastatic Breast Cancer

    Hormone receptor-positive, HER2-negative breast cancer

    Hormonal therapy is considered the standard initial treatment for HER2-negative metastatic breast cancer that is also hormone receptor-positive. It is often given in combination with targeted therapy. However, chemotherapy may also be given. A clinical trial may also be an option for treatment at any stage.

    Hormone receptor-negative, HER2-negative breast cancer

    In general, chemotherapy or targeted therapy is given for treatment of triple-negative breast cancer. A clinical trial may also be an option for treatment at any stage.

    HER2-positive breast cancer that has spread to parts of the body other than the brain

    In general, HER2-targeted therapy is regularly added to treatment for HER2-positive breast cancer that has spread. The drugs used depend on the treatments already given and whether the cancer is hormone receptor-positive. The treatment recommendations for first-line, second-line, and third-line or higher treatment are described below. A clinical trial may also be an option for treatment at any stage.

    First-line treatment

    Second-line treatment

    • For people with advanced breast cancer that has grown during or after first-line treatment with a HER2-targeted therapy, ASCO recommends trastuzumab deruxtecan as a second-line treatment.

    Third-line or higher treatment

    HER2-positive breast cancer that has spread to the brain


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