Patient Observation for Malignant neoplasm of breast

Phase-Based Progress Estimates
Malignant neoplasm of breast+15 More
Patient Observation - Other
All Sexes
What conditions do you have?

Study Summary

This trial studies pembrolizumab to see how well it works in treating triple-negative breast cancer.

Eligible Conditions
  • Malignant neoplasm of breast
  • Breast
  • Stage 0 Breast Cancer AJCC v6 and v7
  • Invasive Breast Carcinoma
  • Triple Negative Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Malignant neoplasm of breast

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Up to 10 years

18 months after randomization
Resolution of treatment-related symptoms in patients receiving pembrolizumab
55 weeks after randomization
Impact of treatment and treatment-related symptoms on physical function in patients without therapy
Physical function
Severity of fatigue
Year 10
Overall survival (OS)
Year 10
Invasive disease-free survival (IDFS)
Year 10
Distant recurrence-free survival (DRFS)
Up to 10 years
Emotional function and disease-related symptoms in patients receiving pembrolizumab
Incidence of adverse events
Relationship between treatment-related symptoms and adherence to the study medication
Single nucleotide polymorphisms (SNPs) in the promotor region of pro-inflammatory cytokine genes and the risk for development and severity of treatment-associated fatigue and other symptoms
Up to 55 weeks
Role of pro-inflammatory cytokines in the development of pembrolizumab associated symptoms
Month 60
Long-term quality of life and symptoms between the two treatment groups

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Malignant neoplasm of breast

Trial Design

2 Treatment Groups

Arm II (pembrolizumab)
1 of 2
Arm I (observation)
1 of 2
Experimental Treatment

1155 Total Participants · 2 Treatment Groups

Primary Treatment: Patient Observation · No Placebo Group · Phase 3

Arm II (pembrolizumab)Experimental Group · 5 Interventions: Quality-of-Life Assessment, Radiation Therapy, Laboratory Biomarker Analysis, Questionnaire Administration, Pembrolizumab · Intervention Types: Other, Radiation, Other, Other, Biological
Arm I (observation)Experimental Group · 5 Interventions: Quality-of-Life Assessment, Radiation Therapy, Patient Observation, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Other, Radiation, Other, Other, Other
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
Completed Phase 3
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,297,733 Total Patients Enrolled
Lajos PusztaiPrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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If the ER and/or HER2 results are different between the initial, pre-chemotherapy, and post-chemotherapy surgical tissue, the receptor status of the residual disease is used to determine eligibility
Patients must not have metastatic disease (i.e., must be clinically M0 or Mx), and they must not have locally recurrent disease
The patient had documented evidence of disease in the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and only had one sentinel lymph node removed after neoadjuvant chemotherapy.
to be eligible for surgery A patient who has a sentinel node biopsy before starting neoadjuvant treatment and does not have a post-neoadjuvant assessment of the axillary nodes, or who has negative axillary nodes on post-neoadjuvant assessment, must have a >= 1 cm residual invasive cancer in the breast after completion of neoadjuvant chemotherapy in order to be eligible for surgery.
Patients who had a documented pathologic involvement of the axillary nodes before neoadjuvant chemotherapy and who also had a sentinel node biopsy after neoadjuvant chemotherapy that was positive were included in the study.
, a complete ALND should be performed at the time of pathology stage I-IIA NSCLC resection
Patients must have a minimum of five, available unstained formalin-fixed paraffin-embedded (FFPE) slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to a central laboratory to determine PD-L1 expression); the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide; central testing is required even if local PD-L1 results are available.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Atlantic Health Sciences Corporation-Saint John Regional Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%