PLD Chemotherapy for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TX
Breast Cancer+2 More
PLD Chemotherapy - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

CD40 Agonist, Flt3 Ligand, and Chemotherapy in Triple Negative Breast Cancer

See full description

Eligible Conditions

  • Breast Cancer
  • Metastatic Breast Cancer, Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PLD Chemotherapy will improve 1 primary outcome and 6 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Baseline, After Cycle 1 (~4 weeks).

6 months
Clinical benefit rate (CBR) by RECIST v1.1 with administration of CDX-1140, CDX-301, and PLD chemotherapy.
Week 4
Anti-tumor immune response by on-treatment CD8 T cell infiltrate
Month 12
Median Progression Free Survival by RECIST v1.1 with administration of CDX-1140, CDX-301, and PLD chemotherapy.
Month 12
Overall Response Rate(ORR) by RECIST v1.1 with administration of CDX-1140, CDX-301, and PLD chemotherapy.
Month 12
Safety (tolerability) of the drug combination of CDX-1140, CDX-301 and PLD as measured by the number of participants with Dose Limiting Toxicity (DLT)
Week 4
Change in CD8 T cell infiltrate
Month 12
Duration of Response(DoR) by RECIST v1.1 to CDX-1140, CDX-301, and PLD chemotherapy.

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Cohort A
1 of 3
Cohort B
1 of 3
Cohort C
1 of 3
Experimental Treatment

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. PLD Chemotherapy is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort APLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression. CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle until toxicity or progression for up to 24 months. CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 1 and 2 only.
Cohort BPLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle starting on cycle 2 until toxicity or progression. CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle until toxicity or progression for up to 24 months. CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 1 and 2 only.
Cohort CPLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression. CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle starting on cycle 2 until toxicity or progression for up to 24 months. CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 2 and 3 only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2011
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 12 months for reporting.

Who is running the study

Principal Investigator
S. R.
Prof. Sangeetha Reddy, Assistant Professor of Medicine
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Unresectable Stage III or Stage IV Triple Negative Breast cancer
Age 18 years or older
Performance status ECOG 0-2
Life expectancy ≥ 12 weeks
Documented progressive disease, based on radiographic, clinical or pathologic assessment, during or subsequent to last anticancer therapy.
For initial safety cohort, subject is in second to third line setting of treatment for metastatic or unresectable disease, and have received 1 to 2 prior regimens for metastatic or unresectable disease. For dose expansion, subject is in first to third line setting of treatment for metastatic or unresectable disease, and have received 0 to 2 prior regimens for metastatic or unresectable disease.
Among any patient enrolled in the first line treatment setting, subjects must be PD-L1 negative by either SP142 or 22C3 assay and not be eligible for FDA approved standard of care chemotherapy and anti-PD-1/PD-L1 combination therapy as alternative to this clinical trial.
Screening laboratory values must meet the following criteria
Neutrophils ≥ 1500/uL
Platelets ≥ 100 x109/L

Patient Q&A Section

What causes triple negative breast neoplasms?

"Results from a recent paper describes the occurrence of triple negative breast neoplasms in our population and the histological types of these malignant neoplasms, in particular, those of a triple negative type, as compared to the known data in the literature. Despite the higher occurrence of these types of neoplasms in our sample, the treatment of these women requires the careful evaluation of the treatment modalities used so as to avoid and prevent the appearance of this form of breast malignancy." - Anonymous Online Contributor

Unverified Answer

What is triple negative breast neoplasms?

"The most common types of breast cancer are ductal carcinoma and lobular carcinomas. More than 70% of breast cancers also carry a triple negativity status. On pathological examination, triple negative breast cancers are similar to breast cancers that do not carry triple negativity. The clinical course seems worse for triple negative breast cancer than for breast cancers that do not carry triple negativity." - Anonymous Online Contributor

Unverified Answer

What are the signs of triple negative breast neoplasms?

"The signs of triple negative breast neoplasms include nipple discharge and a palpable mass in a biopsy-proven case of triple negative breast neoplasms. These are likely to be the first signs of the disease. However, their presence does not automatically rule out benign triple negative breast neoplasms." - Anonymous Online Contributor

Unverified Answer

Can triple negative breast neoplasms be cured?

"Despite these findings, TPB do NOT represent truly curable neoplasms. A combination of chemotherapy and surgical ablation should be considered for most cases unless they exhibit extensive disease at time of diagnosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for triple negative breast neoplasms?

"Treatment for triple negative breast cancers can be a difficult decisions due to the limited therapeutic options. The most common options include surgery, radiation, chemotherapy, targeted therapy, and combination of these techniques. In many cases, metastasis and recurrence are the most lethal aspects of TNBC patients. To overcome this disease, it is very important to find more efficient and effective treatments." - Anonymous Online Contributor

Unverified Answer

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

"This is the first report to describe the incidence of triple negative breast neoplasms and the number of women diagnosed with BRCA1/2 mutations and the number of women diagnosed with BRCA1-related breast cancer in American women. The incidence of triple negative breast neoplasms are increasing in the United States, so there is probably an ongoing increase in BRCA1/2 testing for younger women in the United States." - Anonymous Online Contributor

Unverified Answer

How quickly does triple negative breast neoplasms spread?

"TNBCs have the potential for fast spread. The presence of two or more ILCs should raise suspicion that an ILC may be high grade. Patients with a known ILC should be counseled on the importance of regular and frequent cancer screenings to monitor for the development of further problems." - Anonymous Online Contributor

Unverified Answer

What is the latest research for triple negative breast neoplasms?

"We summarize published, recently published, or unpublished experimental data for our patients with triple negative breast neoplasms. The available data suggest that the tumor expresses epithelial cell adhesion molecules (CAM) that have a critical role in cell-cell interactions and invasion, similar to other types of cancers. As such, therapies targeting these molecules in triple negative neoplasms have the potential to inhibit tumor growth during both experimental and clinical settings and, in turn, significantly enhance the patients' survival duration." - Anonymous Online Contributor

Unverified Answer

Has pld chemotherapy proven to be more effective than a placebo?

"Pld chemotherapy is effective in improving the rate of p53 wild-type disease in the primary breast cancer sites of patients with a triple-negative phenotype. It is well tolerated, less costly, and less radical than neoadjuvant cyclophosphamide before surgery. This finding may impact the future of TNBC treatment in the future with the availability of p53-targeted therapies." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pld chemotherapy for therapeutic use?

"Based on the results of these trials, it seems clear that the combination of paclitaxel with bevacizumab might be the preferred first-line therapy for this aggressive disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets triple negative breast neoplasms?

"The majority of TNBC occur in women over 50. The age distribution for TNBC in our series correlates with historical numbers, supporting the relevance of "no age limits to screening" for this type of breast cancer. More studies are needed to establish the incidence of TNBC in women older than 50 years." - Anonymous Online Contributor

Unverified Answer

What does pld chemotherapy usually treat?

"We consider pld chemotherapy useful for the following indications: (a) age ≥40 years, tumor diameter ≥20 mm (T1/2), and 1-2 lesions, (b) previous chemotherapy (C/V), high Ki-67, estrogen receptor-positive tumors, and (c) the high risk of distant failures following induction C/V treatment." - Anonymous Online Contributor

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