liDERA GO42784


A study to evaluate the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer.

Trial summary:

A study to evaluate the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer. (GO42784)

Receptor status / problem studied:

HR-Positive, HER2-Negative Early Breast Cancer

Inclusion criteria

  • Participants (females, regardless of menopausal status, and males) who are age >=18 years at the time of signing the Informed Consent Form
  • Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as >=1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
  • Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
  • Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for estrogen receptor (ER) positivity and HER2 negativity
  • Participants must have undergone definitive surgery of the primary breast tumor(s)
  • Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization
  • Participants for whom resolution of all acute toxic effects of prior anticancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
  • Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy (ET) are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
  • Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing, with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study

Exclusion criteria

  • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC
  • Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the Sponsor not to be scientifically or medically compatible with this study
  • Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
  • Participants who have active cardiac disease or history of cardiac dysfunction
  • Participants who have been diagnosed with Stage IV breast cancer
  • Participants who have a history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS).┬áParticipants with a history of contralateral DCIS treated by only local
    regional therapy at any time may be eligible

View more trial information

Open for recruitment

Trial Title

liDERA

Diagnosis

Breast cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

III

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