ER+, HER2-, Metastatic Breast CancerPhase 1AZD9833NCT04818632
AZD9833 China PK Study
A Phase 1 study testing AZD9833, AZD9833 with palbociclib and AZD9833 with everolimus in people with ER+, HER2-, Metastatic Breast Cancer, run by AstraZeneca at 4 sites in China.
Trial summary
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- ER+, HER2-, Metastatic Breast Cancer
- What is being tested?
- AZD9833, AZD9833 with palbociclib and AZD9833 with everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesChina
- Study dates
- 12 Nov 2021to 7 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any menopausal status:
- Pre-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to the start of study intervention and must be willing to continue to receive LHRH agonist therapy for the duration of the study.
- Post-menopausal defined according to standard criteria in the protocol.
- Histological or cytological confirmation of adenocarcinoma of the breast.
- Documented positive ER status and HER2 negative status of primary or metastatic tumour tissue.
- ECOG performance status 0 to 1.
Show all 12Show fewer
- Metastatic disease and radiological or objective evidence of progression on or after the last systemic therapy prior to the start of study intervention.
- At least one lesion as per RECIST Version 1.1 that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI, or plain X-ray or clinical examination.
- Recurrence or progression on at least one line of endocrine therapy in the metastatic disease setting.
- For Part A and Part B cohort 1, patients should be eligible for SERD monotherapy treatment.
- For Part B Cohort 2, patients should be eligible for SERD treatment and CDK4/6 inhibitors, and prior treatment with CDK4/6 inhibitors is not permitted.
- For Part B Cohort 3, patients should be eligible for SERD treatment and mTOR inhibitors, and prior treatment with mTOR inhibitors is not permitted.
Who cannot join
- Previous treatment with AZD9833.
- Presence of life-threatening metastatic visceral disease, uncontrolled CNS metastatic disease or life-threatening extensive hepatic involvement.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or infection requiring intravenous antibiotic therapy, which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Inadequate bone marrow reserve or organ function.
- Any clinically important and symptomatic heart disease.
- Any concurrent anti-cancer treatment.
- Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833 (and palbociclib and everolimus).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Research Site
Beijing, 100142
Research Site
Chengdu, 610041
Research Site
Shanghai, 200032
Research Site
Wuhan, 430022
About this study
Official title: A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib or Everolimus in Chinese Patients With Oestrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (mBC)
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
Read the detailed description
This study is designed to investigate and characterize the safety, tolerability and PK of AZD9833 monotherapy (Part A, Part B-cohort 1) or in combination with palbociclib (optional Part B cohort 2) or everolimus (optional Part B cohort 3) and to explore the preliminary anti-tumour activity in Chinese patients
- Conditions
- ER+, HER2-, Metastatic Breast Cancer
- Being tested
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Keywords
- Breast Cancer, Open-label, Phase 1, Safety, Tolerability, Pharmacokinetics, ER Positive, HER2 Negative, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9833Drug
Part A: AZD9833 monotherapy dose escalation.
AZD9833Drug
Part B: AZD9833 monotherapy dose expansion
AZD9833 with palbociclibDrug
Part B: AZD9833 with palbociclib dose expansion
AZD9833 with everolimusDrug
Part B: AZD9833 with everolimus dose expansion
| Study group | Role | What they receive |
|---|---|---|
| AZD9833 monotherapy dose escalation | Experimental | Not described Receives: Drug: AZD9833 |
| AZD9833 monotherapy dose expansion | Experimental | Not described Receives: Drug: AZD9833 |
| AZD9833 with palbociclib dose expansion | Experimental | Not described Receives: Drug: AZD9833 with palbociclib |
| AZD9833 with everolimus dose expansion | Experimental | Not described Receives: Drug: AZD9833 with everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with dose-limiting toxicity, as defined in the protocol.
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria of AZD9833 monotherapy. [part A only]
Measured: Minimum observation period 28 days on treatment.
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed by CTCAE v5.0 of AZD9833 monotherapy.
Measured: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
Plasma AZD9833 concentrations and derived PK parameters.
To characterise the single- and multiple-dose PK of AZD9833 monotherapy.
Measured: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
Secondary outcomes (7)
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed by CTCAE v5.0 of AZD9833 administered in combination with palbociclib or everolimus..
Measured: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
Plasma AZD9833 concentrations and derived PK parameters (for optional expansion cohorts Part B Cohorts 2 and 3 only). Everolimus (whole blood) concentrations and derived PK parameters (for optional expansion cohort Part B Cohort 3 only).
To characterise the single- and/or multiple-dose PK of AZD9833 administered in combination with palbociclib, and single- and/or multiple-dose PK of both AZD9833 and everolimus in combination.
Measured: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
Objective Response Rate
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: Week 8 and week 16 and week 24 and then every 12 weeks (week 36, 48, 60) until the end of the study (approximately 1 year)
Duration of Response
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
Clinical benefit rate at 24 weeks
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: Up to 24 weeks
Percentage Change in Tumour Size
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
Progression Free Survival
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: From start of treatment to disease progression/latest date of evaluable RECIST assessment (approximate 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start12 Nov 2021
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER+, HER2-, Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiong Wu, Principal investigator, Department of Breast Surgery, Fudan University Shanghai Cancer CenterJian Zhang, Principal investigator, Department of Medical Oncology, Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818632
- Sponsor's protocol ID
- D8530C00007
- Acronym
- AZD9833
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination With Palbociclib or Everolimus in Chinese Patients With Oestrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (mBC)
- ClinicalTrials.gov ID
- NCT04818632
- Acronym / sponsor ID
- AZD9833 / D8530C00007
- Conditions
- ER+, HER2-, Metastatic Breast Cancer
- Keywords
- Breast Cancer, Open-label, Phase 1, Safety, Tolerability, Pharmacokinetics, ER Positive, HER2 Negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
Detailed description
This study is designed to investigate and characterize the safety, tolerability and PK of AZD9833 monotherapy (Part A, Part B-cohort 1) or in combination with palbociclib (optional Part B cohort 2) or everolimus (optional Part B cohort 3) and to explore the preliminary anti-tumour activity in Chinese patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD9833 monotherapy dose escalation | Experimental | Drug: AZD9833 |
| AZD9833 monotherapy dose expansion | Experimental | Drug: AZD9833 |
| AZD9833 with palbociclib dose expansion | Experimental | Drug: AZD9833 with palbociclib |
| AZD9833 with everolimus dose expansion | Experimental | Drug: AZD9833 with everolimus |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Any menopausal status:
- Histological or cytological confirmation of adenocarcinoma of the breast.
- Documented positive ER status and HER2 negative status of primary or metastatic tumour tissue.
- ECOG performance status 0 to 1.
- Metastatic disease and radiological or objective evidence of progression on or after the last systemic therapy prior to the start of study intervention.
Key exclusion criteria (8 listed)
- Previous treatment with AZD9833.
- Presence of life-threatening metastatic visceral disease, uncontrolled CNS metastatic disease or life-threatening extensive hepatic involvement.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or infection requiring intravenous antibiotic therapy, which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Inadequate bone marrow reserve or organ function.
- Any clinically important and symptomatic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9833Part A: AZD9833 monotherapy dose escalation. | Drug | AZD9833 monotherapy dose escalation |
| AZD9833Part B: AZD9833 monotherapy dose expansion | Drug | AZD9833 monotherapy dose expansion |
| AZD9833 with palbociclibPart B: AZD9833 with palbociclib dose expansion | Drug | AZD9833 with palbociclib dose expansion |
| AZD9833 with everolimusPart B: AZD9833 with everolimus dose expansion | Drug | AZD9833 with everolimus dose expansion |
Primary outcome
The number of subjects with dose-limiting toxicity, as defined in the protocol.
Time frame: Minimum observation period 28 days on treatment.
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria of AZD9833 monotherapy. [part A only]
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed by CTCAE v5.0 of AZD9833 monotherapy.
Plasma AZD9833 concentrations and derived PK parameters.
Time frame: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
To characterise the single- and multiple-dose PK of AZD9833 monotherapy.
7 secondary outcomes
The number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: 6 months after the last patient recruited starts study intervention or 28 days after the final patient discontinues study intervention
Plasma AZD9833 concentrations and derived PK parameters (for optional expansion cohorts Part B Cohorts 2 and 3 only). Everolimus (whole blood) concentrations and derived PK parameters (for optional expansion cohort Part B Cohort 3 only).
Time frame: At predefined intervals throughout the AZD9833 treatment period (approximately 16 weeks )
Objective Response Rate
Time frame: Week 8 and week 16 and week 24 and then every 12 weeks (week 36, 48, 60) until the end of the study (approximately 1 year)
Duration of Response
Time frame: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
Clinical benefit rate at 24 weeks
Time frame: Up to 24 weeks
Percentage Change in Tumour Size
Time frame: Week 8 and week 16 and week 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year)
Progression Free Survival
Time frame: From start of treatment to disease progression/latest date of evaluable RECIST assessment (approximate 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- AstraZenecaClinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiong Wu principal investigator
Department of Breast Surgery, Fudan University Shanghai Cancer Center
Jian Zhang principal investigator
Department of Medical Oncology, Fudan University Shanghai Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9833, AZD9833 with palbociclib and AZD9833 with everolimus in people with ER+, HER2-, Metastatic Breast Cancer, run by AstraZeneca at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with dose-limiting toxicity, as defined in the protocol. (time frame: Minimum observation period 28 days on treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.