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1

NEAREST SITE: 72 miles
Investigational Site Number 8400019
Woodland, CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04059484

SAR439859 for Advanced ER+ Breast Cancer in Postmenopausal Women

An Open Label Randomized Phase 2 Trial of SAR439859, Versus Endocrine Monotherapy as Per Physician's Choice in Premenopausal and Postmenopausal Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies Scientific Title

Purpose
To compare the anti-cancer activity and side effects of the experimental anti-estrogen drug SAR439859 with anti-estrogen drugs already approved and commonly used.
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2 negative (HER2-) breast cancer treated who have received no more than one chemotherapy or targeted therapy for metastatic disease.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859 is a type of anti-estrogen drug called a selective estrogen receptor degrader (<span class="highlight">SERD</span>) which binds to and breaks down estrogen receptors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04059484' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793484' target='_blank'>NCI Drug Dictionary: SAR439859</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/HormoneTherapies.html' target='_blank'>Susan G. Komen: Hormone Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: SERD</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/78/13_Supplement/943' target='_blank'>Journal Abstract: SAR439859</a> </li><li class='seamTextUnorderedListItem'><a href='https://jhoonline.biomedcentral.com/articles/10.1186/s13045-018-0620-6' target='_blank'>Journal Article: Overcoming Endocrine Resistance in Metastatic Hormone Receptor-positive Breast Cancer</a> </li></ul>
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2

NEAREST SITE: 339 miles
Investigational Site Number 8400029
Santa Monica, CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04478266

An Experimental Anti-Estrogen Therapy and a CDK 4/6 Inhibitor for Advanced, ER+, HER2- Breast Cancer

A Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease Scientific Title

Purpose
To compare the anti-cancer activity and safety of giving the experimental anti-estrogen therapy SAR439859 in combination with palbociclib (Ibrance®) to giving the standard anti-estrogen therapy letrozole (Femara®) in combination with palbociclib.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet started treatment for advanced or metastatic disease.    Full eligibility criteria
Contact research site
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental: SAR439859 and Palbociclib</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly, ongoing (if you are a pre/perimenopausal woman or a man)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Letrozole and Palbociclib</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for SAR439859, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly, ongoing (if you are a pre/perimenopausal woman or a man)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SAR439859 is a type of experimental anti-estrogen therapy called a selective estrogen receptor degrader (<span class="highlight">SERD</span>) which binds to and breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. It is approved for treating metastatic hormone positive, HER2 negative breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used in combination with either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04478266' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-breast-cancer-by-stage/treatment-of-stage-iv-advanced-breast-cancer.html' target='_blank'>American Cancer Society: Treatment of Stage IV (Metastatic) Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/next-generation-endocrine-therapy-moves-forward-in-breast-cancer-trial' target='_blank'>OncLive: Next-Generation Endocrine Therapy Moves Forward in Breast Cancer Trial</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: SERD</a> </li></ul>
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3

NEAREST SITE: 353 miles
Site 5
Los Angeles, CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03560531

Targeted Therapy ZN-c5 For Advanced ER+, HER2- Breast Cancer

A Phase I Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Previously Treated Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer Scientific Title

Purpose
To look at the safety, best dose and effects (good and bad) of ZN-c5 when it is used alone or in combination with palbociclib (Ibrance®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have already been treated with a hormone therapy.    Full eligibility criteria
Contact research site
Close

Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-c5, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-c5, by mouth</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-c5 is a type of anti-estrogen therapy called a <span class="highlight">SERD</span> (selective estrogen receptor degrader), which binds to and breaks down estrogen receptors. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a targeted drug used to treat metastatic breast cancer in combination with a hormone therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03560531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: SERD</a> </li></ul>
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4

NEAREST SITE: 671 miles
Site 2
Gilbert, AZ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04514159

Experimental Anti-Estrogen ZN-C5 and Abemaciclib for Advanced, ER+, HER2- Breast Cancer

A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer Scientific Title

Purpose
To study the safety, side effects and anti-cancer activity of giving the experimental anti-estrogen therapy ZN-C5 in combination with the CDK 4/6 inhibitor abemaciclib (Verzenio®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not already received a CDK 4/6 inhibitor.    Full eligibility criteria
Contact research site
Close

Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will recieve the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily (twice a day), ongoing </li> <li class="seamTextUnorderedListItem">ZN-C5, by mouth, daily (once or twice a day), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-C5 is a type of anti-estrogen therapy called a <span class="highlight">SERD</span> (selective estrogen receptor degrader), which binds to and breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04514159' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://zentalis.com/#pipeline' target='_blank'>Zentalis Pharmaceuticals Drug Information Page: ZN-C5</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: SERD</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ajmc.com/view/in-drug-pricing-pbms-called-the-arsonist-and-the-firefighter-in-one-' target='_blank'>American Journal of Managed Care (video): Dr Joanne Mortimer Discusses Novel Oral SERD ZN-c5 in ER-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/verzenio' target='_blank'>Breastcancer.org: Abemaciclib</a> </li></ul>
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5

NEAREST SITE: 682 miles
Site 5
Seattle, WA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04176757

ZN-C5 for Stage I, II, III, and IV ER+, HER2- Breast Cancer

A Phase 1 Open-Label, Multicenter Study to Evaluate Biomarkers for ZN-c5 in Subjects With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Scientific Title

Purpose
To determine the best dose of the investigational drug ZN-c5.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) estrogen positive (ER+), HER2 negative (HER2-) breast cancer.    Full eligibility criteria
Contact research site
Close

Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-c5, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-c5 is a type of hormone therapy called a <span class="highlight">SERD</span> (selective estrogen receptor degrader).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04176757' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zentalis.com/#pipeline' target='_blank'>Drug Company Information Page: ZN-C5</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: Selective Estrogen Receptor Degrader (SERD)</a> </li></ul>
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