Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

NCT04576455

Active Not RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Interventions: Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist

Countries: United States, Argentina, Australia, Brazil, China, Germany, Israel, Poland

This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Women who are postmenopausal or premenopausal/perimenopausal
* For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
* Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
* Treatment with any investigational therapy within 28 days prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction
* Pregnant or breastfeeding
Locations (81)
  • Marietta, Georgia, United States
  • Cleveland, Ohio, United States
  • Tigard, Oregon, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Mendoza, Argentina
  • Rosario, Argentina
  • San Nicolás, Argentina
  • Darlinghurst, New South Wales, Australia
  • St Albans, Victoria, Australia
  • Fortaleza, Ceará, Brazil
  • Ijuí, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • Changchun, China
  • Guangzhou, China
  • Linyi, China
  • Nanchang, China
  • Shanghai, China
  • Tianjin, China
  • Wuhan, China
  • Xi'an, China
  • Zhejiang, China
  • Aschaffenburg, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Paderborn, Germany
  • Stralsund, Germany
  • Ashdod, Israel
  • Jerusalem, Israel
  • + 51 more on CT.gov