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Welcome!

Thank you for your interest in the Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) Study.

Recruitment for these studies is now complete

The ELAINE Study is evaluating an investigational oral drug in postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor 2-negative (HER2-) breast cancer that have shown progression on previous treatment with an aromatase inhibitor (Al) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor and who have an estrogen receptor 1 (ESR1) mutation. Estrogen receptor mutations have been found in up to 40% of women who progress on endocrine therapy and confer resistance and negatively impact prognosis.1
A second study, ELAINE 2, is studying the safety and tolerability of an investigational oral drug in postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic ER+/HER2-breast cancer that have shown progression on previous treatment with an AI in combination with a CDK 4/6 inhibitor and who have an ESR1 mutation. Each ELAINE study is assessing different treatment outcomes and has its own unique design and enrollment requirements.

What is lasofoxifene? 2

Lasofoxifene is being investigated as an oral selective estrogen receptor modulator, or SERM, for the treatment of certain patients with metastatic breast cancer. Lasofoxifene has been studed in over 10,000 women in prior non-oncology clinical studies.3 This has helped us understand more about lasofoxifene to better characterize its safety and tolerability profile.

We are evaluating whether lasofoxifene may slow the progression of disease and improve quality of life in patients who have metastatic breast cancer with ESR1 mutations.

About metastatic
breast cancer
How do I qualify for
the ELAINE Study?
Why participate in
the ELAINE Study?
Who is Elaine?

About metastatic breast cancer

Each year, ~250,000 women are diagnosed with breast cancer in the United States (US). It is estimated that 20% to 30% will develop advanced or metastatic breast cancer.4 More than 150,000 women in the US are living with metastatic breast cancer.5 While treatments such as endocrine therapy and CDK 4/6 inhibitors are a mainstay for metastatic breast cancer, resistance to treatment eventually almost always develops.6

For women with ER+ metastatic breast cancer, resistance to endocrine therapy can present serious challenges. There are many reasons for endocrine resistance, but one major cause is developing an ESR1 mutation. If you are one of the ~30% of women with ER+ metastatic breast cancer who has developed an ESR1 mutation, current endocrine treatments such as aromatase inhibitors may not work as well for you.7

We are investigating whether oral lasofoxifene may benefit certain women with metastatic breast cancer by delaying disease progression while offering a potentially differentiated safety profile that may impact quality of life and symptoms of vaginal dryness.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you.

Click Here »

How do I qualify for the ELAINE Study

The ELAINE Study is evaluating an investigational drug in postmenopausal women with ER+/HER2- breast cancer that have shown progression on previous AI treatment in combination with a CDK 4/6 inhibitor and who have an ESR1 mutation.*

You may qualify to participate in the study if you:

  • Are postmenopausal
  • Have been diagnosed with locally advanced or metastatic ER+/HER2-  breast cancer
  • Have been diagnosed with an acquired ESR1 mutation. This may have been detected in previous testing by your doctor and if not, a liquid biopsy as part of the study will be done to see if the mutation is present
  • Had disease progression after taking an AI in combination with a CDK 4/6 inhibitor*

If you pre-qualify based on inclusion and exclusion criteria, you will receive a liquid biopsy blood test at no cost to determine if you have an acquired ESR1 mutation prior to enrollment in the study.

*AIs include Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane). CDK 4/6 inhibitors include Kisqali (ribociclib), Ibrance (palbociclib), and Verzenio (abemaciclib).

All product names, trademarks, and registered trademarks are property of their respective owners.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you.

Click Here »

Why participate in The ELAINE Study?

If you qualify and decide to enroll in the study, you will:

  • Receive a screening blood test to determine if you have the ESR1 mutation at no cost
  • Receive study-related medical care and study-related medication at no cost
  • Receive close monitoring and state-of-the-art care during the study

Not every patient participating in The ELAINE Study will receive investigational lasofoxifene. We will be evaluating whether this investigational drug may slow the progression of metastatic breast cancer and improve quality of life markers compared to those individuals that will receive standard treatment.

Your participation in the ELAINE study could help us learn more about this investigational drug and may help other people with this disease in the future.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you.

Click Here »

Make a difference: participate in research

  • Clinical trials may offer a source of hope—for you, and those who follow in your shoes
  • Clinical trials allow researchers to study new treatments that may be better than what’s currently available
  • If you’ve been diagnosed with cancer, a clinical trial may offer access to the latest and most promising science
  • Virtually every therapy currently on the market was made possible by people participating in clinical trials

Many cancer clinical trials are not completed because not enough people participate, so a promising treatment may never get approved. Find out more about participating in research today!

Who is Elaine?

The ELAINE Study is dedicated in memory of Elaine Davidson Nemzer, MD, the sister of Sermonix co-founder Miriam Davidson Portman, MD. Elaine was a brilliant and compassionate child psychiatrist whose life was cut short by metastatic breast cancer at the age of 47. She was the author of several textbook chapters on psychiatry and a dedicated therapist, teacher, colleague, wife, mother, sister, and friend. Even during her illness, she was a source of comfort and hope to all those she encountered, and her spirit continues to serve as an inspiration to the Sermonix team, filling us with passion and purpose.

About metastatic breast cancer

Each year, ~250,000 women are diagnosed with breast cancer in the United States (US). It is estimated that 20% to 30% will develop advanced or metastatic breast cancer.4 More than 150,000 women in the US are living with metastatic breast cancer.5 While treatments such as endocrine therapy and CDK 4/6 inhibitors are a mainstay for metastatic breast cancer, resistance to treatment eventually almost always develops.6

For women with ER+ metastatic breast cancer, resistance to endocrine therapy can present serious challenges. There are many reasons for endocrine resistance, but one major cause is developing an ESR1 mutation. If you are one of the ~30% of women with ER+ metastatic breast cancer who has developed an ESR1 mutation, current endocrine treatments such as aromatase inhibitors may not work as well for you.7

We are investigating whether oral lasofoxifene may benefit certain women with metastatic breast cancer by delaying disease progression while offering a potentially differentiated safety profile that may impact quality of life and symptoms of vaginal dryness.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you. Click Here »

How do I qualify for The ELAINE Study?

The ELAINE Study is evaluating an investigational drug in postmenopausal women and premenopausal women on ovarian suppression with ER+/HER2- breast cancer that have shown progression on previous AI treatment in combination with a CDK 4/6 inhibitor and who have an ESR1 mutation.*

You may qualify to participate in the study if you:

  • Are a postmenopausal woman or premenopausal woman on ovarian suppression therapy
  • Have been diagnosed with locally advanced or metastatic ER+/HER2- breast cancer
  • Have been diagnosed with an acquired ESR1 mutation. This may have been detected in previous testing by your doctor, and if not, a liquid biopsy as part of the study will be done to see if the mutation is present
  • Had disease progression after taking an AI in combination with a CDK 4/6 inhibitor*

If you pre-qualify based on inclusion and exclusion criteria, you will receive a liquid biopsy blood test at no cost to determine if you have an acquired ESR1 mutation prior to enrollment in the study.

*AIs include Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane). CDK 4/6 inhibitors include Kisqali (ribociclib),  Ibrance (palbociclib), and Verzenio (abemaciclib).

All product names, trademarks, and registered trademarks are property of their respective owners.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you. Click Here »

Why participate in The ELAINE Study?

If you qualify and decide to enroll in the study, you will:

  • Receive a screening blood test to determine if you have the ESR1 mutation at no cost
  • Receive study-related medical care and study-related medication at no cost
  • Receive close monitoring and state-of-the-art care during the study
Not every patient participating in The ELAINE Study will receive investigational lasofoxifene. We will be evaluating whether this investigational drug may slow the progression of metastatic breast cancer and improve quality of life markers compared to those individuals who will receive standard treatment.

Your participation in the ELAINE study could help us learn more about this investigational drug and may help other people with this disease in the future.

See if you pre-qualify for The ELAINE Study. Use the ZIP code locator to find contact information for the study location nearest you. Click Here »

Make a difference—participate in research

There are several reasons to participate in a research study8:

  • Clinical trials may offer a source of hope—for you, and those who follow in your shoes
  • Clinical trials allow researchers to study new treatments that may be better than what’s currently available
  • If you’ve been diagnosed with cancer, a clinical trial may offer access to the latest and most promising science
  • Virtually every therapy currently on the market was made possible by people participating in clinical trials

Many cancer clinical trials are not completed because not enough people participate, so a promising treatment may never get approved. Find out more about participating in research today!

Who is Elaine?

The ELAINE Study is dedicated in memory of Elaine Davidson Nemzer, MD, the sister of Sermonix co-founder Miriam Davidson Portman, MD. Elaine was a brilliant and compassionate child psychiatrist whose life was cut short by metastatic breast cancer at the age of 47. She was the author of several textbook chapters on psychiatry and a dedicated therapist, teacher, colleague, wife, mother, sister, and friend. Even during her illness, she was a source of comfort and hope to all those she encountered, and her spirit continues to serve as an inspiration to the Sermonix team, filling us with passion and purpose.

Find a Study Location

References:
1. Jeselsohn R. Are we ready to use ESR1 mutations in clinical practice? Breast Care (Basel). 2017;12(5):309-313. 2. Sermonix Pharmaceuticals announces recent closure of $4.2 million seed preferred equity bridge to fund operations, prepare for phase II breast cancer study [press release]. Columbus, OH: Sermonix Pharma; October 31, 2017. https://sermonixpharma.com/sermonix-pharmaceuticals-announces-recent-closure-of-4-2-million-seed-preferred-equity-bridge-to-fund-operations-prepare-for-phase-ii-breast-cancer-study. Accessed October 14, 2019. 3. Plourde PV, Schwartzberg LS, Greene GL, et al. An open-label, randomized, multi-center phase 2 study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer (MBC) with an ESR1 mutation. Poster presented at: 2018 San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, TX. Abstract OT1-01-02. 4. Metastatic Breast Cancer Network. Incidence and incidence rates. MBCN website:  http://mbcn.org/incidence-and-incidence-rates. Accessed October 14, 2019. 5. National Cancer Institute. Study estimates number of U.S. women living with metastatic breast cancer. Cancer.gov. https://www.cancer.gov/news-events/press-releases/2017/metastatic-breast-cancer-survival-rates. Published May 18, 2017. Accessed October 14, 2019. 6. Breastcancer.org. Study offers new reason why some cancers resistant to hormonal therapy. Breastcancer.org website: https://www.breastcancer.org/research-news/new-research-on-hormonal-tx-resistant-cancers. Published November 9, 2015. Accessed October 14, 2019. 7. Reinert T. Saad ED, Barrios CH, Bines J. Clinical implications of ESR1 mutations in hormone receptor-positive advanced breast cancer. Front Oncol. 2017;7:26. 8. American Cancer Society. The basics of clinical trials. American Cancer Society website.  https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/clinical-trial-basics.html. Published May 3, 2016. Accessed October 14, 2019.

The information you provide is completely confidential. The study team respects and protects your privacy.