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JOURNAL ONKOLOGIE – STUDIE
EMBER-2

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

Rekrutierend

NCT-Nummer:
NCT04647487

Studienbeginn:
April 2021

Letztes Update:
16.07.2021

Wirkstoff:
LY3484356

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Eli Lilly and Company

Collaborator:
-

Studienleiter

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com» Kontaktdaten anzeigen

Studienlocations
(3 von 22)

Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change from Baseline in ER Expression (Time Frame - Baseline, Day 15):
ER expression measured by H-score immunohistochemistry (IHC)



Secondary outcome:

1. Change from Baseline in Ki-67 Index (Time Frame - Baseline, Day 15):
Ki-67 index measured by percentage positive scoring by IHC

2. Change from Baseline in Progesterone Receptor (PR) Expression (Time Frame - Baseline, Day 15):
PR expression measured by H-score IHC

3. PK: Plasma Concentration of LY3484356 (Time Frame - Baseline through follow-up at Day 15)

Studien-Arme

  • Experimental: LY3484356 Dose Level 1
    Administered orally.
  • Experimental: LY3484356 Dose Level 2
    Administered orally.

Geprüfte Regime

  • LY3484356:
    Administered orally.

Quelle: ClinicalTrials.gov


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