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Monoclonal Antibodies

Mastectomy for Breast Cancer

Phase 2
Waitlist Available
Led By William E Gillanders
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HER2 negative by FISH or IHC staining 0 or 1+ according to NCCN guidelines
Estrogen receptor (ER) and progesterone receptor (PR) < Allred score of 3 or =< 5% positive staining cells in the invasive component of the tumor (provided the patient is being treated as triple negative breast cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is studying how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer.

Who is the study for?
This trial is for adults with newly diagnosed stage II-III triple-negative breast cancer. They must have normal organ and marrow function, no prior treatment for the disease, and an ECOG performance status of 0-2. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The study tests how well carboplatin and paclitaxel chemotherapy work with or without atezolizumab (an immunotherapy drug) before surgery in shrinking tumors. Patients are randomly assigned to receive either both chemo drugs alone or combined with atezolizumab.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, immune-related issues like inflammation in organs due to atezolizumab, as well as typical chemo side effects such as fatigue, nausea, hair loss, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is HER2 negative based on specific tests.
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My breast cancer is considered triple negative based on hormone receptor tests.
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My breast cancer is at a stage where it has grown but not spread to distant organs.
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I have not received any treatment for my current illness.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer is at a stage where it's grown but not spread to distant organs.
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I am eligible for chemotherapy before surgery.
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I have a new diagnosis of breast cancer confirmed by tissue analysis.
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My cancer is HER2 negative based on specific tests.
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I have a new diagnosis of breast cancer confirmed by a biopsy.
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I can take care of myself but might not be able to do heavy physical work.
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My kidneys are functioning well enough for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Increase in tumor infiltrating lymphocyte (TIL) percentage
Secondary outcome measures
Increase in pathologic complete response (pCR) rate
Other outcome measures
Change in immune response PD-L1 expression
Change in immune response by immune signature
Disease free survival (DFS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (atezolizumab, carboplatin, paclitaxel, breast surgery)Experimental Treatment5 Interventions
Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV over 30 minutes Q3W, and paclitaxel IV over 1 hour QW. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo the collection of blood samples throughout the trial.
Group II: Arm A (carboplatin, paclitaxel, mastectomy, lumpectomy)Active Control5 Interventions
Patients receive carboplatin IV over 30 minutes Q3W and paclitaxel IV over 1 hour QW. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo the collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mastectomy
2017
N/A
~11160
Carboplatin
2014
Completed Phase 3
~6670
Lumpectomy
2008
N/A
~670
Paclitaxel
2011
Completed Phase 4
~5380
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,086 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
William E GillandersPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

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

For what purpose is Mastectomy most commonly performed?

"Though often used for palliative care, mastectomy can also be an effective intervention against other illnesses like malignant peritoneal neoplasm, advanced endometrial cancer, and melanoma."

Answered by AI

How many test subjects are necessary for this research project?

"Currently, this trial is not enrolling patients. The clinical study was originally posted on May 17th 2017 and updated July 2nd of this year. There are 4770 trials for breast cancer and 1511 Mastectomy trials that are currently seeking participants."

Answered by AI

Are there any life-threatening risks associated with Mastectomy?

"While Phase 2 trials don't have efficacy data, the evidence of safety suggests that patients should feel confident in this procedure."

Answered by AI

Are there other scientific papers which explore Mastectomy?

"The first clinical study surrounding mastectomy was conducted in 1997 at City of Hope Comprehensive Cancer Center. As of now, there have been a total 1616 completed trials on this topic. Right now, 1511 studies are ongoing with many of them based in Columbus, Ohio."

Answered by AI

Can you tell me how many hospitals are conducting this trial at the moment?

"There are a total of 14 locations where this study is taking place. Some notable sites include the Ohio State University Comprehensive Cancer Center in Columbus, Mayo Clinic Hospital in Arizona in Phoenix, and Siteman Cancer Center at Saint Peters Hospital in Saint Peters."

Answered by AI

Are new patients still being accepted into this research program?

"At the moment, this clinical trial is not looking for any new candidates. Although, it's worth noting that the study was originally posted on May 17th, 2017 and was edited as recently as July 2nd, 2022. For anyone else interested in participating in a clinical trial, there are 4770 trials for breast cancer and 1511 Mastectomy trials actively recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
2017. "Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02883062.
All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer
~9 spots leftby Apr 2025
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