CLINICAL TRIAL

Trastuzumab deruxtecan for Breast Cancer

Recruiting · 18+ · All Sexes · Shenyang, China

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

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About the trial for Breast Cancer

Eligible Conditions
Metastatic Breast Cancer With HER2 Positive · Breast Neoplasms

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.

Experimental Group 1
Placebo
DRUG
+
Trastuzumab deruxtecan
DRUG
Experimental Group 2
Trastuzumab deruxtecan
DRUG
+
Pertuzumab
DRUG
Control Group 3
Taxane
DRUG
+
Pertuzumab
DRUG
+
Trastuzumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Trastuzumab deruxtecan
FDA approved
Pertuzumab
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must be ≥18 years of age
is advanced or metastatic
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
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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: Assessed up to approximately 104 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Assessed up to approximately 104 months.
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 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.

Serum concentration of trastuzumab deruxtecan and pertuzumab
UP TO CYCLE 8, APPROXIMATELY WEEK 24; EACH CYCLE IS 21 DAYS
Determination of trastuzumab deruxtecan and pertuzumab concentrations in serum.
Duration of Response (DoR) by BICR and Investigator Assessment
UNTIL PROGRESSION OR DEATH (IN THE ABSENCE OF PROGRESSION), ASSESSED UP TO APPROXIMATELY 60 MONTHS
DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression.
Objective Response Rate (ORR) by BICR and Investigator assessment
UNTIL PROGRESSION OR DEATH (IN THE ABSENCE OF PROGRESSION), ASSESSED UP TO APPROXIMATELY 60 MONTHS
ORR is defined as The percentage of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Progression Free Survival (PFS) by Investigator assessment
UNTIL PROGRESSION OR DEATH, ASSESSED UP TO APPROXIMATELY 60 MONTHS
Defined as time from date of randomisation until the date of objective radiological disease progression according to Investigator using RECIST 1.1 or death by any cause.
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
UNTIL PROGRESSION OR DEATH, ASSESSED UP TO APPROXIMATELY 60 MONTHS
Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab.
UP TO FOLLOW-UP PERIOD, APPROXIMATELY 60 MONTHS
Number and percentage of participants who develop anti-drug antibody (ADA) for trastuzumab deruxtecan. Number and percentage of participants who develop ADA for pertuzumab
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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 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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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