Durvalumab for Breast Cancer

1
Effectiveness
2
Safety
Houston Methodist Cancer Center, Houston, TX
Breast Cancer+1 More
Durvalumab - Drug
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a combination of drugs may help treat breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 18 weeks.

18 weeks
Number of participants with treatment-related adverse events
Pathological complete response (pCR) rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
pCR rate in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors
pCR rate in the breast in patients whose tumors have <5% and ≥5% tumor-infiltrating lymphocytes (TILs)
3 years
Three-year disease-free survival (DFS) rate in patients who achieve pCR

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Durvalumab + Trastuzumab + Pertuzumab

This trial requires 39 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab 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.

Durvalumab + Trastuzumab + PertuzumabDurvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Pertuzumab
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
J. C. C.
Jenny C. Chang, MD
The Methodist Hospital Research Institute

Closest Location

Houston Methodist Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients 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:
A person has a baseline left ventricular ejection fraction of greater than or equal to 50%, as measured by a multigated acquisition scan or echocardiogram. show original
The female participant must be over 18 years of age when they enter the study. show original
Breast cancer that is histologically confirmed to be enriched for HER2 and that has an ERBB2 mRNA level of greater than 7.5-10. show original
The patient tested negative for both estrogen receptor and progesterone receptor. show original
Stage I or II disease.
Breast cancer that is not found in a node or nodes. show original
T2 is a disease that affects the brain. show original
Cancers that are found in both breasts are allowed if they individually meet the eligibility criteria. show original
The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 means that a person is able to carry out all normal activities and has no symptoms. show original
The person has adequate organ and marrow function. show original

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 breast cancer?

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Treatment of men with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is much like treatment of women. Common treatment options for breast cancers in men include hormone medication and surgery. Men can also receive chemotherapy, radiation therapy, or a combination of these. Common treatment options for breast cancers in men include axillary surgery and hormone medication. However, in certain cases, surgery may be necessary to remove all cancer cells from the lymphatic system such as in stage III disease. Treatment options for other cancers, including non breast-related cancer types are similar for men and women.

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Can breast cancer be cured?

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The incidence of cure for breast cancer has not declined in the last 30 years. It has, however, been demonstrated that this has not led to a cure in the last 10 years. With very good care, a cure rate of over 90 percent can be achieved.

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What is breast cancer?

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Many women have [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s and many experience discomfort from their first diagnosis. The breast looks like a lumpy pain in the breast or a bump. Some cancer experts even recommend against mammograms, because they think that the chances of a cancer is low. What is breast cancer?

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

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The number of new [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cases reported in 1999 was 8.4% of cases for women aged 50 to 69. At age 70 to 74, the rate was 22.4%. Breast cancer accounts for 16% of deaths in US women ≥ 50. There was a 28% increase in breast cancer mortality from 1987 to 1995. Cancer and Death Statistics, 2000, 2001, 2001-2; U.S. Cancer Registry, 2000; American Cancer Society. American women born in 1900 (incomplete link) U.S. Cancer Information for the Public, 1999-2000, 2001. U.S. Cancer Registry. 2002-. Cancer and Death Statistics, 2002, 2005-6; National Center for Health Statistics.

Unverified Answer

What are the signs of breast cancer?

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The most commonly reported signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in women are the following: a) palpable lump in the breast, and b) pain/swelling in one or both breasts, both of which are the result of local invasion, and c) enlargement of the breast in women who are still menstruating.

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What causes breast cancer?

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Although cancer does have multiple causes, it is usually caused by inheritable genetic risk factors, such as a family history of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) or a mutation in the BRCA1 or BRCA2 gene. Women born to a first degree relative with breast cancer have a 20-50% increased risk of breast cancer themselves, compared with women without a family history. Men-to-women transmission of the BRCA1 and BRCA2 genes is even higher. These women should discuss their risks of breast cancer and should consider early screening with mammography. Men-to-women transmission of other benign or malignant breast tumors has not been studied thoroughly.

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What are the common side effects of durvalumab?

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Durvalumab induced common side effects in patients with advanced (or metastatic) breast cancer. These side effects may result in patient non-adherence despite persistence over time. However, most patients were either compliant with treatment or the side effects were manageable, but many were impacting patients' functionality.

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What are the latest developments in durvalumab for therapeutic use?

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In this review, a summary of the key developments in the therapeutic use of Durvalumab are described. It has been shown to be active and safe in patients receiving it as a monotherapy for HR+/HER2- advanced breast cancer. It may be that this and other anti-PD-1 or anti-PD-L1 inhibitors will provide a new approach to patients with HR+ advanced breast cancer who relapse after standard of care chemotherapy.

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Is durvalumab typically used in combination with any other treatments?

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The combination of durvalumab and the following treatments were found to be the most frequently used combinations: pemetrexed and paclitaxel (3%), capecitabine and pemetrexed (3%), docetaxel, capecitabine and pemetrexed (3%), and docetaxel, capecitabine, and bevacizumab (1%).

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Has durvalumab proven to be more effective than a placebo?

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Durvalumab demonstrated a longer ORR, DFS, and OS compared with placebo and was better than trastuzumab in HR+/HER2+ metastatic breast cancer. Compared with trastuzumab, its benefit was limited.

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What is the survival rate for breast cancer?

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While the survival rate for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is not the lowest when compared to all other cancers, it is lower when the tumor is very small.

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What is the primary cause of breast cancer?

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A cause of estrogen receptor positive breast cancer is unknown. However, an association with obesity and insulin, particularly type II diabetes, raises the possibility of a link between the two. A relationship with obesity, which is increasing in Western society, and the rise in metabolic syndrome and related hyperinsulinaemia is particularly important as the latter is the cause of two-thirds of insulin-treated type II diabetes worldwide.

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