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Atezolizumab + Standard Therapy for HER2-Positive Breast Cancer
Study Summary
This trial is studying how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have brain metastases that meet exclusion criteria.I have a history of specific health conditions related to cancer, heart, nervous system, allergies, skin, immune system, infections, or have had a transplant.I am fully active or can carry out light work.My blood clotting tests are within the required range.I am HIV positive, on treatment, and my viral load is undetectable.I have health issues that could make treatment risky or affect test results.My breast cancer has spread outside the brain and cannot be surgically removed.My cancer can be measured and has not been treated with radiation.I have brain metastases and meet all required criteria.Your lab test results need to be within certain ranges.Patients must have specific initial levels of thyroid-stimulating hormone (TSH) and morning cortisol in their blood.Your diagnosis must have been confirmed by a biopsy of the recurrent or spreading disease.I am either male or female.Your heart function must be checked within 6 weeks before starting the study.My largest tumor is 3 cm or smaller.I have up to four cancer spread sites in my brain.I am 18 years old or older.
- Group 1: Arm I (pertuzumab, trastuzumab, taxane therapy, atezolizumab)
- Group 2: Arm II (pertuzumab, trastuzumab, taxane therapy, placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the Docetaxel FDA status?
"Docetaxel safety is supported by efficacy data from Phase 3 trials, and it received a score of 3."
Are we still able to enroll patients in this research project?
"No, this particular trial is not looking for new patients. It was first posted on March 12th 2019 and last updated November 8th 2020. Although this study is no longer active, there are 7738 other trials that are currently recruiting across a wide variety of topics."
What are some of the primary conditions that Docetaxel is used to target?
"Docetaxel is most commonly used as a treatment for metastatic bladder cancer, however it has also shown efficacy in treating inflammatory breast cancer (ibc) and small cell lung cancer (sclc)."
In how many different locations is this trial being conducted today?
"To try and enrol as many patients as possible, the team conducting this trial set up shop in 100 different locations. A few of these places are Joliet, Indianapolis and Marshalltown but there are many more. If you're interested in participating, choose a location near to reduce travel time demands."
How many people are helping to test this new medication?
"As of now, this study is no longer looking for volunteers. It was originally posted on March 12th, 2019 and last updated on November 8th, 20202. If you want to look into other options, there are 6169 adenocarcinoma studies and 1569 Docetaxel trials currently seeking participants."
What are the most precedent studies to this one involving Docetaxel?
"Out of the 1569 ongoing studies investigating Docetaxel, 402 have reached Phase 3. Many of these clinical trials are based in Seattle, Washington; however, there are 81858 total locations running trials for Docetaxel."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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