CLINICAL TRIAL

Pembrolizumab for Inflammatory Breast Neoplasms

1 Prior Treatment
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a drug may help treat inflammatory breast cancer or triple negative breast cancer.

See full description

About the trial for Inflammatory Breast Neoplasms

Eligible Conditions
Estrogen Receptor Negative · Inflammatory Breast Neoplasms · HER2/Neu Negative · Edema · Stage IV Inflammatory Breast Carcinoma · Breast Neoplasms · Triple Negative Breast Carcinoma · Erythema · Recurrent Inflammatory Breast Carcinoma · Peau d'Orange · Triple Negative Breast Neoplasms · Progesterone Receptor Negative · Carcinoma

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab 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.
Laboratory Biomarker Analysis
OTHER
Pembrolizumab
BIOLOGICAL
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
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Inflammatory Breast Neoplasms or one of the other 12 conditions listed above. 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:
Has a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000 /mcL
Hemoglobin (Hgb) >= 9 g/dL
Creatinine levels < 1.5 x upper limit of normal (ULN)
Is willing and able to provide written informed consent for the trial
Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBC
Has stage IV or recurrent disease that has been treated
Has clinical response or stable disease for minimum of two months (three cycles of every three week chemotherapy or 8 weeks of weekly regimen, etc.) after receiving any prior chemotherapy for metastatic/recurrent disease; a minimum of two cycles (6-8 weeks) of chemotherapy is required to determine clinical response; per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1, clinical response for measurable disease is defined as complete response (CR) or partial response (PR); for non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and pathological lymph nodes >= 10 to < 15 mm short axis) is defined as persistence of one or more non-target lesion(s) and no increase in overall tumor burden
Is HER2 normal, defined as HER2 0 or 1+ by immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (FISH) if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 months post-treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 months post-treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 months post-treatment.
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 Pembrolizumab will improve 1 primary outcome and 3 secondary outcomes in patients with Inflammatory Breast Neoplasms. Measurement will happen over the course of Baseline.

Biomarker analyses
BASELINE
Correlation among biomarkers at baseline in each specimen and between different specimens will be assessed. The association among various continuous and discrete biomarkers or disease status groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc, and may be tested by t-test/analysis of variance/Wilcoxon rank sun test/Kruskal-Wallis test, whichever is appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients.
BASELINE
Overall survival time
UP TO 3 MONTHS POST-TREATMENT
Estimated using Kaplan-Meier method.
UP TO 3 MONTHS POST-TREATMENT
Disease control survival
UP TO 3 MONTHS POST-TREATMENT
Estimated using Kaplan-Meier method.
UP TO 3 MONTHS POST-TREATMENT
Rate of disease control
UP TO 3 MONTHS POST-TREATMENT
Defined as the percentage of patients either with measurable disease that maintain immune complete response (iCR), immune partial response, immune stable disease (iSD), or with non-measurable disease that achieve iCR or iSD, by 4 months or more in all evaluable patients. A disease control rate of 10% or lower will be considered treatment failure and the regimen will be rejected under this circumstance. A 95% exact binomial confidence interval on disease control rate will be computed. Will also perform secondary analysis on intent-to-treat patient population where those patients who drop out early will be considered as progression.
UP TO 3 MONTHS POST-TREATMENT

Patient Q & A Section

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

What are the signs of inflammatory breast neoplasms?

Inflammatory breast neoplasms usually appear as a mass on the breast. They may become painful and red, as well as itch and feel warm to the touch. Symptoms of breast infections are common and usually occur with palpable masses or with a lump on the breast. In addition, some patients experience erythema, edema or tenderness, but other signs and symptoms may not appear until the tumour has progressed. In the final stages of breast cancer, the breast will usually feel lumpy, hot, swollen or hard. As the tumour continues to grow, there may be a lump or nodule on the nipple that is painless or tender. Lymph nodes can be painful and may feel swollen or heavy.

Anonymous Patient Answer

What is inflammatory breast neoplasms?

Inflammatory breast neoplasms occur in 1 out of 1000 to 3000 breast biopsies and involve the tissue between the basement membrane and the underlying connective tissue supporting the epithelium. There are different subtypes according to the pathological pattern of the tumor mass and the localization of the tumor. Clinically, the subtypes include low grade carcinoma with apocrine differentiation, intermediate and high grade carcinoma with spindle cell pattern and the carcinoma in situ. They might have a better prognosis if managed according to the type.

Anonymous Patient Answer

What causes inflammatory breast neoplasms?

IBNs might be caused by a low levels of androgens, estrogens, and progesterone and/or low levels of growth factor. The low levels of progesterone and estrogen might come from the low levels of androgen and the low levels of growth factor. The low levels of testosterone level could be one of the causes. There are also some genes (such as BRCA1, ERBB3, and STAT-3) associated with IBNs, and these genes are related to estrogen.

Anonymous Patient Answer

Can inflammatory breast neoplasms be cured?

Results from a recent paper suggests that IBN may be curable but that the rate of healing may be influenced by the histological type and by patient age.

Anonymous Patient Answer

What are common treatments for inflammatory breast neoplasms?

Different treatment regimens exist for breast cancer associated with inflammatory conditions such as systemic mastocytosis or Behçet's disease. Treatment with chemotherapy followed by surgical resection is appropriate for symptomatic cases. Surgery is the gold standard for curative treatment in most cases, especially in localized disease.

Anonymous Patient Answer

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

About 10 million women in the United States and Canada have a history of breast cancer; nearly 8 million of these cases are due to in-viromeous conditions. IBC accounted for approximately 1% of breast cancers in the United States in 2008. The age-adjusted incidence rate of IBC in the United States was 3.8 per 100,000 women, and it was much higher in black women (13.5 per 100,000) than in white women (2.9 per 100,000). The age-adjusted rate of IBC incidence increased from 3,828 cases in 1992 to 16,531 cases in 1994, and 24,913 cases in 1998.

Anonymous Patient Answer

Does inflammatory breast neoplasms run in families?

Data from a recent study of this study suggest that there are no genetic risk factors predisposing IBN patients and families to develop IBN. A genetic basis for familial susceptibility to IBN is not supported by the results of this investigation.

Anonymous Patient Answer

What are the common side effects of pembrolizumab?

The common adverse drug reactions associated with pembrolizumab are summarized below.\n\n- Hypothyroidism: hypothyroidism is the most common side effect observed with pembrolizumab treatment. The usual clinical signs and symptoms of hypothyroidism are reproduced in the table below.\n- Elevated liver enzymes: Elevated liver enzymes are the most frequent serum enzyme rises observed during the treatment with pembrolizumab. If any of the elevations is significant you could visit, www.powerlab.com: http://www.powerlab.

Anonymous Patient Answer

What is the latest research for inflammatory breast neoplasms?

For the most part, recent research has been geared toward improving our understanding of the molecular basis of the disease, to improving our knowledge of the etiology and progression of the disease, and to improving therapies. For those interested in future research and treatment options for IBN, we recommend using Power (https://www.withpower.com/d/cancer-research) to find clinical trial options tailored to your medical condition and location.

Anonymous Patient Answer

What is pembrolizumab?

Pembrolizumab was well tolerated in this phase II study of metastatic breast cancer patients with a variety of histologic subtypes. Long-term results of the study will be published in 2020. Pembrolizumab did not result in a change in prognosis in either responders or remitters after 6 weeks of therapy. Data from a recent study are not expected to change the current clinical practice of administering pembrolizumab in patients with metastatic breast cancer patients with hormone receptor-positive and/or HER2/neu overexpressing tumors who are hormone receptor positive, HER2/neu positive, or either in patients who have an orphan, or BRCA1/BRCA2 mutation.

Anonymous Patient Answer

What are the chances of developing inflammatory breast neoplasms?

It is estimated that in the general USA population, the chances of developing IBNs in a woman are 1.2 in 2000, and the chances of IBNs progressing to Invasiveness is 1.2 in 2500.

Anonymous Patient Answer

What is the primary cause of inflammatory breast neoplasms?

There is ample biological evidence to support a viral-induced proliferative cascade in the pathogenesis of invasive breast lesions. This concept provides an explanation for the high prevalence of non-neoplastic breast lesions in association with invasive breast cancer and emphasizes the importance of the biologic properties of the neoplastic cascade to its pathogenesis.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Inflammatory Breast Neoplasms by sharing your contact details with the study coordinator.