A Randomised, Double-Blind, Phase III Study of AZD9833 plusPalbociclib versus Anastrozole plus Palbociclib in Patients with ER-Positive HER2-Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

JRCT ID: jRCT2031210041

Registered date:15/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ER-Positive HER2-Negative Breast Cancer
• Date of first enrollment: 15/04/2021
• Target sample size: 1342
• Countries of recruitment: United States,Japan,Belgium,Japan,Canada,Japan,Hungary,Japan,India,Japan,Italy,Japan,Republic of Korea,Japan,Malaysia,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Russia,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

AZD9833 : 75 mg, PO, once daily
AZD9833 placebo : PO, once daily
Palbociclib : PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment
Anastrozole : 1 mg, PO, once daily
Anastrozole placebo : PO, once daily
LHRH agonist : SC, once monthly

Outcome(s)

Primary Outcome

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 [ Time Frame: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years) ]

PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.

- De novo Stage 4 disease, or recurrence from early stage disease after standard adjuvant endocrine therapy meeting either one of the following criteria:

a. Received at least 24 months of AI treatment as part of their adjuvant therapy and at least 12 months have elapsed since the patient's last adjuvant AI therapy without disease progression on treatment.

b. Received at least 24 months of tamoxifen treatment as part of their adjuvant endocrine therapy

- Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results.

- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.

- Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI.

- Eastern Cooperative Oncology Group performance status of 0 or 1.

- Adequate organ and marrow function.

- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclude criteria

- Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment.

- Previous treatment with AZD9833.

- Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

- Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.

- Any clinically important and symptomatic heart disease .

- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

- Any concurrent anti-cancer treatment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Information

• Primary Sponsor: Yamaji Shigeyuki
• Secondary ID(s): NCT04711252