Breast Cancer Clinical Trial

A Trial to Find Out How Well Camizestrant Together With Palbociclib Works in Participants With a Type of Advanced Breast Cancer That Has ER Proteins But no Overexpression of HER2 Protein.

Summary

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.

View Full Description

Full Description

Researchers are looking for a better way to treat breast cancer.

In people with cancer, some cells have grown out of control to form tumours.

The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer.

In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein.

The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse.

The trial will split participants into 2 groups:

Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole.
Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant.

A placebo looks like a treatment but does not have any medicine in it.

A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible.

The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take:

camizestrant or anastrozole once daily by mouth
palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days

Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if:

They are medically determined yet to reach menopause status
They are male

They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing.

Participants will take trial treatment until the cancer gets worse or they leave the trial.

Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA

INFORMATION FOR TRIAL PARTICIPANTS

Participants can join the trial if they:

Have breast cancer that cannot be treated with surgery or radiation
Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment
Have ER proteins but not overexpression of HER2 protein in their tumors
Have never received any type of cancer therapy that affects the whole body for advanced breast cancer
Are able to do their daily activities

Full list of inclusion 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 at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
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 with a soft tissue component 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.

EXCLUSION CRITERIA

INFORMATION FOR TRIAL PARTICIPANTS

Participants cannot join the trial if they:

Have uncontrolled cancer that has spread to the brain or the spinal cord
Have received certain treatments for cancer in the past but the cancer came back within 1 year
Had certain types of tumors in the past, which the study doctors think could come back
Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body
Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant

Full list of exclusion 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.
Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
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 and/or impending visceral crisis
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.
Active infection including tuberculosis, HBV and HCV.

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1342

Study ID:

NCT04711252

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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Mobile Alabama, 36604, United States
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Springdale Arkansas, 72762, United States
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Harbor City California, 90710, United States
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Lone Tree Colorado, 80124, United States
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Fort Myers Florida, 33901, United States
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Freiburg , 79110, Germany
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Zalaegerszeg , 8900, Hungary
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Łódź , 90-30, Poland
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Kaluga , 24800, Russian Federation
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Kislino Village, Ryshkovsky Ru , 30552, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 11799, Russian Federation
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Moscow , 12146, Russian Federation
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Saint-Petersburg , 19010, Russian Federation
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Taipei , 10048, Taiwan
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Taoyuan , 333, Taiwan
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Ankara , 6100, Turkey
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Kayseri , 38039, Turkey
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Birmingham , B15 2, United Kingdom
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Colchester , CO4 5, United Kingdom
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Leeds , LS9 7, United Kingdom
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Northwood , HA6 2, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Surrey , GU2 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1342

Study ID:

NCT04711252

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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