CLINICAL TRIAL

ATEZOLIZUMAB for Breast Cancer

Metastatic
Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a drug called atezolizumab can be used to treat brain metastases in people with HER2-positive breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Central Nervous System Metastases · Metastatic Breast Cancer With HER2 Positive · Neoplasm Metastasis

Treatment Groups

This trial involves 2 different treatments. ATEZOLIZUMAB is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ATEZOLIZUMAB
DRUG
PERTUZUMAB
DRUG
TRASTUZUMAB
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eligible participants who have surgery with residual un-treated lesions remaining may enroll in the study immediately, providing that at least one untreated lesion is measurable. show original
People who have had WBRT and/or SRS in the past and whose lesions have progressed since then are also eligible to participate show original
A person is considered to have an ECOG performance status of 0 or 1 if they are considered to be in good or very good health, respectively. show original
The patient must have a left ventricular ejection fraction (LVEF) of 50% or more by either an echocardiogram (echo) or multigated acquisition (MUGA) scan within 28 days of the first day of the study. show original
Pathologically confirmed HER2-positive MBC by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization with a ratio of HER2-gene signals to centromere 17 signals ≥ 2.0 or average HER2 copy number ≥ 6.0 signals/cells) show original
, was detected on MRI in 78% of patients with EGFR mutation-positive NSCLC and measurable brain metastases at baseline show original
All patients will have their eligibility assessed as part of the screening procedures. show original
People who have not been treated with radiation therapy to the brain (WBRT or SRS) before are eligible to enter the study, but they must not be symptomatic from their CNS metastases and not require corticosteroids for symptom control. show original
Both patients with systemic stable or absent disease and patients with progressive disease are eligible for this trial as long as they meet one of the above criteria. show original
The patient should take a stable dose of dexamethasone for at least 7 days before beginning treatment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 Years
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ATEZOLIZUMAB will improve 1 primary outcome and 9 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 24 Weeks.

Overall Response Rate in CNS
24 WEEKS
Assessed using RANO-BM criteria
24 WEEKS
Progression Free Survival
24 WEEKS
Assessed using RANO-BM criteria
24 WEEKS
Objective non-CNS response rates
24 WEEKS
According to RECIST 1.1 and irRC criteria
24 WEEKS
Clinical Benefit Rate
18 AND 24 WEEKS
Incidence of SD, PR, or CR in non-CNS by RECIST 1.1 and in CNS by RANO-BM
18 AND 24 WEEKS
Dose Limiting Toxicity
BASELINE WITHIN 21 DAYS OF C1D1 TREATMENT
Toxicity will be graded according to NCI CTCAE, Version 4.0. Toxicities will be summarized by maximum grade. Kaplan-Meier product-limit estimates and 90% confidence bands
BASELINE WITHIN 21 DAYS OF C1D1 TREATMENT
Investigator-Assessed Neurological Evaluation
2 YEARS
Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale
2 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get breast cancer a year in the United States?

Around 275,000 cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are diagnosed each year in the US, making it the second most common cancer in American women. Gender of the patient does not influence the prognosis, as the chance of the cancer recurs is similar in men and women.

Anonymous Patient Answer

What are the signs of breast cancer?

Nodes near the breast, nipple, or axilla might be palpated or feel lumpy, hard or tender to the touch. Women with breast cancer may also have lump or bump behind the armpit or groin and may have white patches or sores on their skin. Skin that does not appear normal can have redness, scaling, itching and rash. The size and shape of the breast can be seen by inspection and may vary by tumor type. Women with breast cancer may have changes in sensation, especially numbness, tingling, swelling or loss of sensation in the breasts.\n

Anonymous Patient Answer

What are common treatments for breast cancer?

The majority of women with breast cancer are treated to some degree; the use of chemotherapy may be higher for younger women. Rarely are patients treated with mastectomy; however, this may be advisable if their only option is a mastectomy.

Anonymous Patient Answer

What is breast cancer?

Patients can live longer than people diagnosed with other cancers, although the disease has a tendency to recur. It is a malignant disease, although many of the symptoms are less specific than typical cancer symptoms. Because of the number of women diagnosed, the lifetime risk is higher than any other cancer. Breast cancer affects more women than any other cancer. The disease is strongly associated with hormonal factors. Treatment requires a multidisciplinary approach, which generally includes surgery and chemotherapy, but the use of antiestrogens and trastuzumab in the neoadjuvant setting is also expanding. Treatment is expensive, but not, in most cases, completely effective, so relapse remains inevitable.

Anonymous Patient Answer

What causes breast cancer?

Recent findings provides evidences for the effect of cigarette smoking on breast cancer. The present work on cigarette smoking is also to be of interest for prevention and treatment of breast cancer.

Anonymous Patient Answer

Can breast cancer be cured?

Although the majority of patients with stage 4 breast cancer do not survive to 5 years after diagnosis, some patients with stage 0-3 can be cured with adequate chemotherapy. These patients can sometimes become completely asymptomatic and have a long-term prognosis without further treatment.

Anonymous Patient Answer

How does atezolizumab work?

Atezolizumab effectively blocks PD-1 and is the first antibody therapy that specifically inhibits PD-1. In clinical trials, patients treated with atezolizumab were shown to have an increase in survival as well as an increase in progression-free survival. Atezolizumab was shown to be well-tolerated and had activity against several types of breast cancer.

Anonymous Patient Answer

What is atezolizumab?

Atezolizumab improves progression-free survival in metastatic breast cancer in patients with HER2-positive or HER2-gene-amplified tumors. Clinical benefits of atezolizumab were greater in patients with tumors that overexpress a high HER2/neu level or that overexpress the hormone receptors. No meaningful difference was observed in those with tumors that only express a high HER2/neu level or those with tumors that have low levels of the receptor.

Anonymous Patient Answer

Is atezolizumab typically used in combination with any other treatments?

Patients with metastatic breast cancer who have progressed on or after platinum and taxane-based chemotherapy have a shorter median time to progression after atezolizumab treatment compared with patients treated with conventional therapies. In contrast, patients who respond to chemotherapy at the time of progression have longer progression-free survivals than patients treated with atezolizumab. The atezolizumab-based combination in this setting may help to prolong progression-free survival and prolong overall survival in patients who have progressed on their first-line treatment.

Anonymous Patient Answer

What is the primary cause of breast cancer?

Obesity, alcoholism, excess estrogen and smoking are known hereditary risk factors for breast cancer. This is the most important risk factor of breast cancer among Indian women.

Anonymous Patient Answer

What does atezolizumab usually treat?

Atezolizumab as a monotherapy is active in patients with metastatic tumors and shows promise as a second- or third-line immunotherapy. However, the majority of patients with a response to atezolizumab will have progressive disease that was previously under-treated or untreated.

Anonymous Patient Answer

Has atezolizumab proven to be more effective than a placebo?

Overall, we observed no significant difference in response rate or progression-free survival between atezolizumab and controls. We also observed no difference in response rate or time to progression between the two groups in patients who achieved partial response or stable disease.

Anonymous Patient Answer
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