PECS-1 for Breast Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Breast Cancer+2 More
PECS-1 - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication

See full description

Eligible Conditions

  • Breast Cancer
  • Malignant Neoplasm of Female Breast

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether PECS-1 will improve 1 primary outcome in patients with Breast Cancer. Measurement will happen over the course of 30 days from study treatment.

Day 30
Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

PVB + PECS-1
1 of 3
PVB
1 of 3
Serratus + PECS-1
1 of 3
Experimental Treatment

This trial requires 1500 total participants across 3 different treatment groups

This trial involves 3 different treatments. PECS-1 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 4 and have been shown to be safe and effective in humans.

PVB + PECS-1Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes. For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor.
PVB
Drug
Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes.
Serratus + PECS-1For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor. For the serratus block, the patient will be placed in the supine or lateral decubitus position and with an ultrasound probe, in the parasagittal plane, the serratus muscles will be identified. Injections will be done in-plane below the serratus anterior.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days from study treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days from study treatment for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female patients >/= 18 years old
Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR)
Scheduled for surgery at Josie Robertson Surgical Center (JRSC)
Must be appropriate for an agree to receive a nerve block
Must be appropriate for randomization
Able to read and speak English
Willing and able to provide written informed consent

Patient Q&A Section

What is breast cancer?

"A diagnosis of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) will disrupt the social and occupational lives of many women. It is likely many will not live long enough to experience the full consequences of their personal cancer experience. Some women will be reassured by their diagnosis: it helps them accept the realities of their illness and gives them a sense of their own power. Most women will, however, experience challenges of adjustment to their illness and their treatment, including the loss of a spouse, a reduction in social activities and participation, work limitation, treatment discontinuance, and grief." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The cause of breast cancer is still unknown. There is evidence that genetics plays a role, and studies are ongoing to determine whether other factors such as environmental or lifestyle factors play a large role in causing breast cancer." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Although our data suggest improvement in a minority of women in this population, it will be difficult to establish whether or not breast cancer is curable." - Anonymous Online Contributor

Unverified Answer

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

"Women in the United States experience an average of 79,600 new invasive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cases a year. Approximately 6,000 women are diagnosed with breast cancer each year. Breast cancer is the most common form of cancer among women (22.1%), followed by colorectal (11.7%) and colorectal carcinoma (9.3%). Most women who develop breast cancer (70.8%) are older than age 65 years. The average age at diagnosis of breast cancer is 61.1 years. A small percentage of breast cancer develops from a hereditary precondition." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Early signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include breast mass, enlargement, warmth, and bleeding. Painful, swollen lymph nodes also indicate advanced disease that requires systemic therapy such as chemotherapy or hormonal treatment. A lump in the breast is an inconsistent sign that requires medical evaluation.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Most cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are discovered before symptoms are noticed. People are also less likely to get treatment if they have an income of under $45,000 per year. Patients with estrogen receptor-positive breast cancer are more likely to obtain surgery. Radiation is associated with a decreased risk of developing other cancers, such as multiple myeloma, lung cancer, or leukemia. The use of a mammogram and breast self-examination are associated with a 15% decrease in breast cancer, but the number of people undergoing these preventive measures is insufficient to reduce overall breast cancer rates." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"The average age that breast cancer occurs in the United States is 54.4. In the period 1992-2001, the age at diagnosis increased from 53.0 years in 1992 to 54.4 years in 2000 (r=.25, p=0.011). Older age at diagnosis (52.6 years in 2005) was associated with higher grade (p=0.038), N stage (p=0.014), and distant metastasis (p=0.016). The incidence rate of breast cancer was inversely related to time since diagnosis (r=.22, p=0.001). Women from the most recent cohorts (2005) were significantly younger than controls from the prior decade (1989) (55." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Recent findings of this study suggest that there is a significant genetic predisposition to breast cancer, although the mechanism underlying this predisposition is not well understood and deserves further research." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pecs-1?

"Pecs-1 has been found to significantly increase HDL-cholesterol with no adverse effects. The risk of cholesterol changes in the body can be seen to be lower than that of placebo without significant effect on HDL-cholesterol levels." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"Although there is considerable variability regarding the efficacy of antiestrogen therapies, adjuvant chemotherapy is one of the most important determinants of outcome for breast cancer, and many advances in this area are ongoing." - Anonymous Online Contributor

Unverified Answer

Has pecs-1 proven to be more effective than a placebo?

"The pecs-1 group experienced a significantly more rapid decline in neutrophils and less change in LY per liter over the first 10 weeks of treatment, but there was no difference in other neutrophil parameters and hemoglobin counts. The group received a lower dose of cytarabine per course and experienced fewer chemotherapy-related adverse events." - Anonymous Online Contributor

Unverified Answer

What is pecs-1?

"PEPS1 is a key factor in the cellular stress response that can also regulate other cellular processes important for cellular homeostasis and viability. It was first identified in mice by two labs independently in different mammalian cell lines. It has been shown with numerous in vitro and in vivo studies to function by altering a wide range of biological and pathological processes. It was later shown to have an anti-apoptotic role in human cancers. Thus, the peptide might be developed as a novel anti-cancer 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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