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1

Saruparib PARP1 Inhibitor with <span class="highlight">Camizestrant</span> Hormone Therapy for Advanced HR+, HER2- or HER2 Low Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

EvoPAR-BR01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus <span class="highlight">Camizestrant</span> Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus <span class="highlight">Camizestrant</span> for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Br...

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of saruparib, an experimental PARP1 inhibitor, with <span class="highlight">camizestrant,</span> an experimental hormone therapy, to standard of care CDK4/6 inhibitor with hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer with BRCA1, BRCA2, or PALB2 mutations. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305), by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Camizestrant,</span> by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Camizestrant,</span> by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305) is an experimental targeted therapy called a PARP1 inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06380751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D9722C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/next-generation-parp-inhibitor-demonstrates-clinical-benefit-in-patients-with-homologous-recombination-repair-deficient-breast-cancer/' target='_blank'>AACR: Saruparib for Homologous Recombination Repair Deficient Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>AACR: Camizestrant for Hormone Receptor Positive, HER2 Negative Breast Cancer</a> </li></ul>
1

Saruparib PARP1 Inhibitor with <span class="highlight">Camizestrant</span> Hormone Therapy for Advanced HR+, HER2- or HER2 Low Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

EvoPAR-BR01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus <span class="highlight">Camizestrant</span> Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus <span class="highlight">Camizestrant</span> for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Br...
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Nearest Location from 94107:
336 miles
Research Site
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06380751

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Phase III

2

<span class="highlight">Camizestrant</span> Plus Ribociclib as First Treatment for Advanced Hormone Receptor Positive (ER+), HER2 Negative Breast Cancer

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of <span class="highlight">Camizestrant</span> Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a combination of two oral drugs: <span class="highlight">camizestrant,</span> a hormone therapy, and ribociclib (Kisqali®), a targeted therapy. The goal is to learn how well this combination works as a first treatment for advanced breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor-positive (ER+), HER2-negative (HER2-) breast cancer who have not yet received any treatment for their advanced or metastatic disease. If your cancer came back after earlier treatment, at least 12 months must have passed since your last dose of hormone therapy (aromatase inhibitor) with no cancer growth during that time. If you were previously on tamoxifen, a 2 week break from that medication is required before joining. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Camizestrant</span> (AZD9833), by mouth, once daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, once daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant works by attaching to estrogen receptors on cancer cells and breaking them down, cutting off the estrogen supply that ER+ cancer cells depend on to grow.</li> <li class="seamTextUnorderedListItem">Ribociclib blocks proteins (CDK4/6) that cancer cells need to divide and multiply, helping slow the cancer's growth.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07647328' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: What Are CDK4/6 Inhibitors?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/XRAY/treating-advanced-breast-cancer-with-ESR1-mutations' target='_blank'>Force: Study: Treating advanced breast cancer with ESR1 mutations shows promise</a> </li></ul>
2

<span class="highlight">Camizestrant</span> Plus Ribociclib as First Treatment for Advanced Hormone Receptor Positive (ER+), HER2 Negative Breast Cancer

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of <span class="highlight">Camizestrant</span> Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients
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Nearest Location from 94107:
1642 miles
Research Site
Kingwood, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07647328

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Phase III

3

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of AZD8421, an experimental CDK2 inhibitor, with <span class="highlight">camizestrant,</span> an experimental SERD, and a CDK4/6 inhibitor.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421, by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Camizestrant,</span> by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and/or palbociclib (Ibrance®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421 is an experimental type of targeted therapy called a CDK2 inhibitor. CDK2 inhibitors may block the enzyme CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html' target='_blank'>AstraZeneca: AZD8421 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li></ul>
3

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1)
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Nearest Location from 94107:
1643 miles
Research Site
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06188520

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Phase I-II

4

Targeted Therapy <span class="highlight">(Camizestrant</span> and Atirmociclib) for Women with Advanced ER+, HER2- Breast Cancer

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of <span class="highlight">Camizestrant</span> in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">camizestrant</span> combined with atirmociclib in women with advanced breast cancer.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer, whose cancer has come back or progressed after prior treatment, and have received at least one prior line of therapy for advanced disease. Must have received no more than one prior CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib) and have not previously been treated with <span class="highlight">camizestrant,</span> atirmociclib, another next-generation oral SERD, or another experimental CDK inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Camizestrant,</span> by mouth, once daily</li> <li class="seamTextUnorderedListItem">Atirmociclib, by mouth, once daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant is a type of hormonal therapy called a selective estrogen receptor degrader (SERD), which works by breaking down estrogen receptors on cancer cells to help stop the cancer from growing. </li> <li class="seamTextUnorderedListItem">Atirmociclib is an investigational CDK4 inhibitor, a type of targeted therapy that helps block cancer cell growth.</li> <li class="seamTextUnorderedListItem">This trial is looking at how safe it is to take <span class="highlight">camizestrant</span> and atirmociclib together, and whether the combination shows early signs of fighting breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07427394' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/esr1-mutation-switching-to-camizestrant' target='_blank'>Study: Camizestrant Helps Keep Some Metastatic Cancers from Growing.</a> </li></ul>
4

Targeted Therapy <span class="highlight">(Camizestrant</span> and Atirmociclib) for Women with Advanced ER+, HER2- Breast Cancer

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of <span class="highlight">Camizestrant</span> in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)
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Nearest Location from 94107:
1739 miles
Research Site
St Louis, MO

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07427394

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Phase II

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