Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

The patients will receive AZD9833 (Dose A).

The patients will receive AZD9833 (Dose B).

The patients will receive AZD9833 (Dose C).

The patients will receive Fulvestrant (500 mg).

Dosage formulation: AZD9833 tablets will be administered orally.

AZD9833

Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Post-menopausal women with histologically or cytologically confirmed metastatic or loco-regionally recurrent ER-positive HER2-negative breast cancer before randomization and fulfilling all of the inclusion criteria and none of the exclusion criteria will be included.

After the screening visit and confirmation of eligibility, patients will be randomly assigned in a 1:1:1:1 ratio to receive 1 of the following 4 treatments, consisting of 4-week treatment cycles until disease progression (assessed by the Investigator as defined by Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1):

* AZD9833 (Dose A)
* AZD9833 (Dose B)
* AZD9833 (Dose C)
* Fulvestrant (500 mg) During the treatment period, patients will have scheduled visits until treatment discontinuation. After the end of treatment, patients will attend 2 safety follow-up visits (at the time of treatment discontinuation and 28 days later) and will continue to be followed for survival.

As of December 2020, the Sponsor stopped enrolment to Dose C.

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

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

The safety and tolerability of AZD9833 when compared to fulvestrant in women with advanced ER-positive HER2-negative breast cancer was evaluated.

PFS was assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1. PFS was defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or received another anti-cancer therapy prior to progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.

Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.

ORR was assessed by the Investigator as defined by RECIST version 1.1. The ORR was defined as investigator assessed Complete Response or Partial Response prior to progression in patients with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Adjusted response rate was presented in this analysis.

Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.

DoR was assessed by the Investigator as defined by RECIST version 1.1. The DoR was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

The percentage change in tumour size at 16 weeks was obtained for each patient, based on RECIST measurements taken at baseline and at 16 weeks. Tumour size is the sum of the longest diameters of the target lesions (TLs). Percentage change in the sum of longest TLs diameters at 16 weeks was measured.

The OS was defined as the time from randomisation to death due to any cause.

Clinical benefit rate was defined as patients with best objective response of complete response or partial response in the first 25 weeks or who have stable disease for at least 23 weeks after randomization.

Adjusted response rate was presented in this analysis.

Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.

The plasma concentrations of AZD9833 at steady state were evaluated.

The pharmacodynamics of AZD9833 and fulvestrant in a subgroup of patients.

To evaluate the effect of AZD9833 and fulvestrant on the patients' health-related quality of life, as assessed by patient completed HRQoL questionnaires.

AstraZeneca

The patients received AZD9833 75mg oral tablets once daily.

AZD9833 75mg

The patients received AZD9833 150mg oral tablets once daily.

AZD9833 150mg

The patients received AZD9833 300mg oral tablets once daily.

AZD9833 300mg

The patients received Fulvestrant 500 mg via IM injection.

Fulvestrant 500 mg

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Full Analysis Set (FAS) consisted of all randomised patients, with treatment groups assigned in accordance with the randomisation, regardless of the actual treatment received.

At the time of CSR finalization, CSP version 5.0 was available, therefore, CSP version 5.0 was redacted and submitted along with the Results Registration Form.

Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.

Global Clinical Lead

FAS consisted of all randomised patients, with treatment groups assigned in accordance with the randomisation, regardless of the actual treatment received.

Progression-free Survival (PFS)

A subset of the FAS with measurable disease.

Objective Response Rate (ORR)

Duration of Response (DoR)

Percentage Change in Tumour Size at 16 Weeks

Overall Survival (OS)

Clinical Benefit Rate at 24 Weeks (CBR24)

Cycle 1 Day 15 (pre-dose)

Cycle 1 Day 15 (2h)

Cycle 1 Day 15 (4h)

Cycle 2 Day 1 (pre-dose)

The PK Analysis Set consisted of all patients who received at least one dose of AZD9833 per protocol, for whom there is at least one reportable PK concentration.

Plasma Concentrations of AZD9833

Percent Change From Baseline in ER and PgR Expression and Ki67 Labelling Index

Changes From Baseline in Health Related Quality of Life (HRQoL)

Any Adverse Event (AE)

Any AE causally related to treatment

Any AE of CTCAE grade 3 or higher

Any AE of CTCAE grade 3 or higher, causally related to treatment

Any AE with outcome = death

Any AE with outcome = death, causally related to treatment

Any Serious Adverse Event (SAE)

Any SAE, causally related to treatment

Any SAE causing discontinuation of treatment

Any SAE causing discontinuation of treatment, causally related to treatment

Any AE leading to discontinuation of treatment

Any AE leading to discontinuation of treatment, causally related to treatment

Any AE leading to dose reduction

Any AE leading to dose interruption

Safety analysis set consisted of all patients who received any amount of study treatment (AZD9833 or fulvestrant), regardless of whether that was the randomised therapy intended or whether they received therapy without being randomised and for whom any post-dose data are available.

Number of Patients With Adverse Events

The patients received Fulvestrant 500 mg via Intramuscular (IM) injection.

Spots Global Cancer Trial Database for oral serd

Every month we try and update this database with for oral serd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oral serd

Every month we try and update this database with for oral serd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oral serd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.