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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04964934




Registration number
NCT04964934
Ethics application status
Date submitted
30/06/2021
Date registered
16/07/2021

Titles & IDs
Public title
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scientific title
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study
Secondary ID [1] 0 0
2023-503990-39-00
Secondary ID [2] 0 0
D8534C00001
Universal Trial Number (UTN)
Trial acronym
SERENA-6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ER-Positive HER2-Negative Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD9833
Treatment: Drugs - AZD9833 Placebo
Treatment: Drugs - Anastrozole
Treatment: Drugs - Anastrozole placebo
Treatment: Drugs - Letrozole
Treatment: Drugs - Letrozole placebo
Treatment: Drugs - Palbociclib
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Luteinizing hormone-releasing hormone (LHRH) agonist
Treatment: Drugs - Ribociclib

Experimental: AZD9833 + palbociclib, abemaciclib or ribociclib - The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily)

Active comparator: Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib - The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)


Treatment: Drugs: AZD9833
Dosage formulation: AZD9833 tablets will be administered orally

Treatment: Drugs: AZD9833 Placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.

Treatment: Drugs: Anastrozole
Dosage formulation: anastrozole tablets will be administered orally.

Treatment: Drugs: Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.

Treatment: Drugs: Letrozole
Dosage formulation: letrozole tablets will be administered orally.

Treatment: Drugs: Letrozole placebo
Dosage formulation: letrozole placebo tablets will be administered orally.

Treatment: Drugs: Palbociclib
Dosage formulation: palbociclib tablets/capsules will be administered orally

Treatment: Drugs: Abemaciclib
Dosage formulation: abemaciclib tablets will be administered orally

Treatment: Drugs: Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

Treatment: Drugs: Ribociclib
Dosage formulation: ribociclib tablets will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1)
Timepoint [1] 0 0
From randomization until the earlier of the progression event or death (approximately 2 years)
Secondary outcome [1] 0 0
Progression-free survival 2 (PFS2)
Timepoint [1] 0 0
From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (approximately 3.5 years)
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
From randomization until the date of death due to any cause (approximately 5 years)
Secondary outcome [3] 0 0
Chemotherapy free survival
Timepoint [3] 0 0
From randomization until the earlier of the start date of chemotherapy or death due to any cause (approximately 5 years)
Secondary outcome [4] 0 0
Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
Timepoint [4] 0 0
From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 5 years)
Secondary outcome [5] 0 0
Clinical benefit rate at 24 weeks (CBR24)
Timepoint [5] 0 0
At least 23 weeks after randomisation for each patient (1 week window for RECIST assessment)
Secondary outcome [6] 0 0
Change from baseline in EORTC QLQ-C30 scale scores
Timepoint [6] 0 0
From baseline until second progression (approximately 5 years)
Secondary outcome [7] 0 0
Change from baseline in EORTC QLQ-BR23 scale scores
Timepoint [7] 0 0
From baseline until second progression (approximately 5 years)
Secondary outcome [8] 0 0
Plasma concentration of AZD9833 at specified timepoints
Timepoint [8] 0 0
on Day 15 for each patient

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

INFORMATION FOR TRIAL PARTICIPANTS - Participants can join the trial if they:

* Have advanced breast cancer that is not able to be treated with surgery or radiation;
* Have an ESR1 mutation in their cancer;
* Have breast cancer that is HR-positive and HER2-negative;
* Are currently being treated with a CDK4/6 inhibitor and an AI and have been taking these drugs for at least 6 months;
* Have not had their cancer get worse after taking an AI and CDK4/6 inhibitor;
* Are able to do their daily activities;
* Are at least 18.

Full list of inclusion criteria:

* Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent;
* Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results;
* Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) ± LHRH as the initial endocrine based treatment for advanced disease;
* Eastern Cooperative Oncology Group performance status of 0 or 1;
* ESR1m detected by central testing of ctDNA;
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
* Adequate organ and marrow function.

EXCLUSION CRITERIA:

INFORMATION FOR TRIAL PARTICIPANTS - Participants cannot join the trial if they:

* Had certain types of tumors in the past that may come back;
* Are currently taking any other treatments for their cancer or other conditions including hormone replacements, medications, or supplements that could interfere with the trial treatment;
* Have or have had any major health problem, infection, or recent surgery that could make it difficult or dangerous to participate in this trial.

Full list of exclusion criteria:

* 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 evidence of severe or uncontrolled systemic 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;
* Patient with known or family history of severe heart disease;
* Previous treatment with AZD9833, investigational SERDs or fulvestrant;
* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding;
* Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/11/2027
Actual
Sample size
Target
Accrual to date
Final
312
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Subiaco
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
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United Kingdom
State/province [190] 0 0
Guildford
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Liverpool
Country [192] 0 0
United Kingdom
State/province [192] 0 0
London
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Manchester
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Newport
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Nottingham
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Portsmouth
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Reading
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sheffield
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Sutton
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04964934