Clinical Trials /

A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

NCT04647487

Description:

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
  • Official Title: EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17575
  • SECONDARY ID: J2J-MC-JZLB
  • SECONDARY ID: 2020-002810-42
  • NCT ID: NCT04647487

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
LY3484356LY3484356 Dose Level 1

Purpose

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

Trial Arms

NameTypeDescriptionInterventions
LY3484356 Dose Level 1ExperimentalAdministered orally.
  • LY3484356
LY3484356 Dose Level 2ExperimentalAdministered orally.
  • LY3484356

Eligibility Criteria

        Inclusion Criteria:

        Participant Must:

          -  Have histologically confirmed invasive ER+, HER2- breast carcinoma

          -  Be willing and able to provide pre- and on-treatment tumor samples

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale

          -  Have adequate organ function

          -  Be able to swallow capsules

        Exclusion Criteria:

        Participant Must Not:

          -  Have bilateral invasive breast cancer

          -  Have metastatic breast cancer

          -  Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer
             therapy

          -  Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer

          -  Have had prior radiotherapy to the ipsilateral chest wall for any malignancy

          -  Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor,
             or other selective estrogen receptor modulator (SERM), either for osteoporosis or
             prevention of breast cancer

          -  Have had prior hormone-replacement therapy within 4 weeks of the start of study
             treatment

          -  Have had major surgery within 28 days prior to randomization to allow for
             post-operative healing of the surgical wound and site(s)

          -  Be pregnant or breastfeeding

          -  Have certain infections such as hepatitis or tuberculosis or HIV that are not well
             controlled

          -  Have another serious medical condition
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change from Baseline in ER Expression
Time Frame:Baseline, Day 15
Safety Issue:
Description:ER expression measured by H-score immunohistochemistry (IHC)

Secondary Outcome Measures

Measure:Change from Baseline in Ki-67 Index
Time Frame:Baseline, Day 15
Safety Issue:
Description:Ki-67 index measured by percentage positive scoring by IHC
Measure:Change from Baseline in Progesterone Receptor (PR) Expression
Time Frame:Baseline, Day 15
Safety Issue:
Description:PR expression measured by H-score IHC
Measure:PK: Plasma Concentration of LY3484356
Time Frame:Baseline through follow-up at Day 15
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • SERD

Last Updated

December 4, 2020