CLINICAL TRIAL

Talimogene Laherparepvec for Carcinoma, Ductal

Waitlist Available · 18+ · Female · Los Angeles, CA

This study is evaluating whether a combination of talimogene laherparepvec, ipilimumab, and nivolumab is safe and effective in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer.

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About the trial for Carcinoma, Ductal

Eligible Conditions
Carcinoma, Ductal · Anatomic Stage II Breast Cancer AJCC v8 · Prognostic Stage IIIA Breast Cancer AJCC v8 · Prognostic Stage IIA Breast Cancer AJCC v8 · Breast Neoplasms · Anatomic Stage IIB Breast Cancer AJCC v8 · Prognostic Stage 0 Breast Cancer AJCC v8 · Carcinoma · Anatomic Stage 1 Breast Cancer AJCC v8 · Anatomic Stage IB Breast Cancer AJCC v8 · Prognostic Stage 1 Breast Cancer AJCC v8 · Prognostic Stage IB Breast Cancer AJCC v8 · Progesterone Receptor Negative · Invasive Ductal Carcinoma, Not Otherwise Specified · Anatomic Stage IIA Breast Cancer AJCC v8 · Prognostic Stage IIIB Breast Cancer AJCC v8 · HER2/Neu Negative · Anatomic Stage IIIB Breast Cancer AJCC v8 · Triple Negative Breast Carcinoma · Prognostic Stage IA Breast Cancer AJCC v8 · Prognostic Stage 2 Breast Cancer AJCC v8 · Prognostic Stage IIB Breast Cancer AJCC v8 · Breast Carcinoma In Situ · Anatomic Stage 0 Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Anatomic Stage IIIA Breast Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Talimogene Laherparepvec 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
BIOLOGICAL
Talimogene Laherparepvec
BIOLOGICAL
Ipilimumab
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
Nivolumab
FDA approved
Talimogene laherparepvec
FDA approved
Ipilimumab
FDA approved

Eligibility

This trial is for female patients aged 18 and older. 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:
A woman has localized, palpable, biopsy proven triple negative or ER positive HER2 negative infiltrating ductal breast cancer with size > 1.5 cm by palpation show original
AST and ALT levels below 2.5 times the institutional upper limit of normal are considered normal. show original
The subject's bilirubin level should be less than 1.5 times the upper limit of normal, and less than 3 times the upper limit of normal for subjects with documented or suspected Gilbert's disease. show original
A patient is considered to have an ECOG performance status of 0 if they are fully active and able to carry out all normal activities show original
A blood test result of Absolute neutrophil count >= 1,500/mm^3 means that a person's blood has at least 1,500 white blood cells per cubic millimeter. show original
The text explains that a platelet count of at least 100,000/mm^3 is desired for a person to donate blood. show original
This tumor is easy to feel and to inject with medication. show original
Hemoglobin >= 9 g/dL
Written informed consent must be obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Albumin >= 2.5 g/dl
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
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 Talimogene Laherparepvec will improve 1 primary outcome and 1 secondary outcome in patients with Carcinoma, Ductal. Measurement will happen over the course of Up to 100 days after last study drug.

Incidence and severity of adverse events (AEs)
UP TO 100 DAYS AFTER LAST STUDY DRUG
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 toxicity criteria. AEs will be tabulated by type, severity, and the proportion of subject experiencing the event.
UP TO 100 DAYS AFTER LAST STUDY DRUG
histopathological evaluation of changes of tumor for inflammatory infiltration and tumor necrosis
UP TO 2 YEARS
Results will be reported using purely descriptive statistics. . All subjects that received any study therapy will be included in the analysis. This is a descriptive study, efficacy will be assessed by histological observations. No criteria for tumor response by its size, i.e. complete response (CR), partial response (PR), are used.
UP TO 2 YEARS

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 common treatments for carcinoma, ductal?

Most of the patients with PDAD received radiotherapy, with estrogen replacement therapy being used more often. Patients with carcinoma of the breast were more likely to receive chemotherapy. This result provides information for clinicians about the general management of patients with carcinoma ductales.

Anonymous Patient Answer

Can carcinoma, ductal be cured?

These data indicate that in patients with low risk, stage I/II breast carcinoma, adjuvant chemotherapy in addition to radical mastectomy seems to be effective in the management of breast carcinoma. The benefit conferred by this treatment must be weighed against its side effects.

Anonymous Patient Answer

What causes carcinoma, ductal?

This may be due to some type of environmental risk factor or genetic factors such as hereditary breast-ovarian, breast-ovarian and [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) familial risk factors. Women are more likely to develop breast cancer in their early - middle age. Cancer of the pancreas, stomach, colon and bladder are common sites of cancers associated with hereditary risk factors for breast-ovarian, breast-ovarian and colorectal cancer. Cancer, not necessarily of blood or bone, is also a likely cause for breast-ovarian, breast-ovarian and colorectal cancer familial risk.

Anonymous Patient Answer

How many people get carcinoma, ductal a year in the United States?

Overall, around 600,000 men and 340,000 women per year get carcinoma, ductal. This could result in an estimated 1,200,000 unnecessary mastectomies each year in men and 630,000 unnecessary mastectomies each year in women.

Anonymous Patient Answer

What are the signs of carcinoma, ductal?

Symptoms, clinical examination, and blood analysis may all be helpful when diagnosing carcinoma, ductal. Clinical examination is the most helpful for distinguishing between carcinoma, ductal versus in situ ductal carcinoma. It can help show whether it was primary or metastatic, and whether the cancer has spread to the lymph nodes. Other signs are blood analysis, and mammography and ultrasound may also be helpful, especially when symptoms may be misdiagnosed.

Anonymous Patient Answer

What is carcinoma, ductal?

Invasive ductal carcinoma has a prevalence of 1 in 100 in Canada and accounts for 80% of breast cancers. Breast cancer has many names, but it is carcinoma, ductal that is most commonly diagnosed and has the highest 5 year survival rate.\n

Anonymous Patient Answer

What is the average age someone gets carcinoma, ductal?

The average age at presentation of an excised breast carcinoma on the whole population of Finland is less than half of the age given in the literature. This is not the case regarding carcinoma, ductal breast, as the average age at presentation to treatment is higher than the median age given in the literature by half a decade (66.2 +/-5 years vs. 55.6 +/-9 years in Finland). The age at presentation is slightly higher for more advanced tumors. A higher age at the early presentation should be an indication to take into account that a diagnosis of breast carcinoma, ductal, should be reconsidered and breast conservation or mastectomy may result in a better survival.

Anonymous Patient Answer

Is talimogene laherparepvec safe for people?

On the basis of these data, it appears that there are no significant differences in survival in the TAL cohort versus conventional CM. TAL should be evaluated in the first or second line following chemotherapy for cancer patients.

Anonymous Patient Answer

What are the common side effects of talimogene laherparepvec?

This case series adds to the spectrum of clinical features observed with GM-CSF treatment, including dermatological signs and symptoms such as acne, seborrhea, folliculitis, and pruritus (itching) that can occur within days of administration. The authors found no clinical evidence for an increased prevalence of autoimmune complications in patients who treated with GM-CSF. The most common side effects were systemic (e.g., nausea, fatigue, and myalgia) and local (e.g., pain and erythema).

Anonymous Patient Answer

How quickly does carcinoma, ductal spread?

Data from a recent study, based on a series of 1032 patients, describes the prognostic factors of a subset of early stage [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients followed up for 3 years and demonstrates that breast carcinoma that spreads to one axilla or other (mamma conserving carcinoma) should receive adjuvant trastuzumab.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, ductal?

Among respondents who responded to the survey, about 4% of women and one-third of men had consulted a medical oncologist about cancer options, and most of the respondents were currently treated. Women were more likely than men to have had consultations about cancer.

Anonymous Patient Answer

Have there been other clinical trials involving talimogene laherparepvec?

Despite the promising efficacy and tolerability data, the number of patients accrued is much less than recommended. Because of limited funding and difficulty in obtaining institutional review boards/ethics committees to review such a rare cancer, this trial would be unlikely to succeed in achieving its goals.

Anonymous Patient Answer
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