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(Last updated: August 03, 2020)

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1

NEAREST SITE: 362 miles
Research Site
Whittier,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04305496

Capivasertib & Fulvestrant or Fulvestrant Alone In Advanced ER+, HER2- Breast Cancer

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After ... Scientific Title

Purpose
To compare the anti-cancer activity of giving the targeted therapy capivasertib in combination with the anti-hormone therapy fulvestrant to giving fulvestrant alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must have already been treated with an aromatase inhibitor and you must not have received more than one chemotherapy and two hormone therapies for advanced or metastatic disease.    Full eligibility criteria
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  • <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">Fulvestrant (Faslodex®), by injection, twice the first month, then once a month, ongoing </li> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, twice a day, 4 days a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice the first month, then once a month, ongoing </li> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice a day, 4 days a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedure for premenopausal women</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A drug that will put you into menopause, by injection, monthly, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is an anti-hormone therapy that is commonly used to treat postmenopausal women with HR+ tumors that have stopped responding to other anti-hormonal therapies.</li> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy that blocks the Akt protein. The Akt protein helps cancer cells divide and grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04305496' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/akt-inhibitor-azd5363' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-fulvestrant-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>OncLive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li></ul>
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