Trastuzumab deruxtecan for Breast Cancer
This study is evaluating whether a combination of two drugs may help treat breast cancer.
See full descriptionAbout the trial for Breast Cancer
Treatment Groups
This trial involves 3 different treatments. Trastuzumab Deruxtecan is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Trastuzumab deruxtecan will improve 1 primary outcome and 11 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to Cycle 8, approximately Week 24; each cycle is 21 days.
Patient Q & A Section
What causes breast cancer?
In this sample of adolescent and young women, risk factors for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) included high parity, nulliparity, early menopause, a female first-degree relative, overweight, and a history of a previous breast cancer. No increased risk was observed in adolescent or young women at increased risk in their mothers who had previous invasive breast cancers. We conclude that breast carcinogenesis is likely different than that occurring in most other women at that age.
What are the signs of breast cancer?
Cancer symptom perception was influenced by the number of symptoms reported. The number of symptoms were significantly associated with worse symptoms among participants who did not seek medical advice. Additional research is warranted to determine the relationship between symptom burden and patient engagement.
Can breast cancer be cured?
The evidence base is weak to support claims to heal (rather than treat) or cure the condition of breast cancer. There is some evidence and good rationale for the treatment of breast cancer. Further study of the efficacy and safety of alternative treatments needs to be conducted.
What are common treatments for breast cancer?
When metastasis or recurrence is suspected, it is commonly managed with systemic therapy. A targeted therapy is mainly selected when specific, sensitive biomarkers have confirmed disease relapse. In order to prevent secondary progression, a trastuzumab-based therapy is usually needed, followed by endocrine treatment for estrogen-driven tumors, targeted therapy for HER2-positive patients, or a combination of both as in breast conserve therapy. Patients usually have a long life expectancy and a good response rate to chemotherapy and target therapy, and a cure is achievable in about 20% of cases on most therapies.
What is breast cancer?
Breast cancer can form in women's breasts. Symptoms depend on whether the cancer has spread and how it has spread. The symptoms have no direct relationship with the size of the tumor. Breast cancer often occurs in conjunction with BRCA gene family cancers, and other forms of hereditary cancers. Symptoms can occur in people without breast cancer.
How many people get breast cancer a year in the United States?
Around 290,000 new cases are expected to be diagnosed and 240,000 are expected to die in the United States in 2019. It is projected that more than 1 in 5 women and 1 in 33 men will be diagnosed with breast cancer at some point in their life.
Have there been any new discoveries for treating breast cancer?
I also discuss the current new treatment, the importance of a cancer screening program, the relevance of treatment in metastatic breast cancer, the use of hormone replacement therapy, and the role of radiotherapy.
What does trastuzumab deruxtecan usually treat?
Trastuzumab deruxtecan should only be initiated in combination with standard adjuvant chemotherapy or chemotherapy combined with targeted agents, or combined with androgen deprivation therapy (ADT), hormone-replacement therapy (HRT) or aromatase inhibitors in breast cancer treatment. Trastuzumab deruxtecan should not be used in untreated cases or metastatic breast cancer or in cases with non-glandular/non-oestrogen positive breast cancer.
Have there been other clinical trials involving trastuzumab deruxtecan?
No current randomized controlled trials have evaluated TRT for the treatment of advanced breast cancer (in combination with paclitaxel), but there are ongoing trials investigating various dosages of this antibody in newly diagnosed metastatic breast cancer patients. The available data suggest that TRT administered continuously at low doses over a period of time represents the best option for patients who do not respond to standard combination chemotherapy regimens.
What are the latest developments in trastuzumab deruxtecan for therapeutic use?
Trastuzumab deruxtecan is an investigational new compound which is still in phase I and II clinical development for the treatment of HER2(+) metastatic breast cancer. It is under investigation as a possible single-agent or in combination with chemotherapy in patients with HER2(+) metastatic breast cancer. Trastuzumab deruxtecan received Fast Track designation by the FDA for this indication in November 2015 and a Breakthrough Therapy designation in June 2016. The initial trial has shown promising results in patients with early HER2(+) metastatic breast cancer.
What is trastuzumab deruxtecan?
Trastuzumab deruxtecan was well tolerated in all patients, but the number of patients who showed clinical response was rather small (3 of 11) with no objective responses. The responses were seen in a dose-independent manner. Based on these results, the use of trastuzumab deruxtecan may be continued in patients with metastatic breast cancer who do not respond to trastuzumab with taxane combination in order to prolong survival.
What is the latest research for breast cancer?
There are many new studies underway to help educate healthcare professionals about the various risk factors and prognosis for breast cancer. However, due to the wide variety of topics and subjects studied, it is often difficult to determine which studies can be applied directly to routine practice that help in the treatment of BC.