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Hormone Therapy

T-DXd Combinations for Breast Cancer (DB-08 Trial)

Phase 1
Waitlist Available
Led By Komal Jhaveri, MD, FACP
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with HR- disease: Part 1 requires at least 1 prior line of chemotherapy for MBC. Part 2 for Module 2 allows no prior lines of therapy for MBC, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed
For patients with HR+ disease: Part 1 requires at least 1 prior treatment line of ET with or without a targeted therapy and at least 1 prior line of chemotherapy for MBC. Part 2 allows only 1 prior treatment line of ET with or without a targeted therapy for MBC and no prior chemotherapy in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to follow-up period, approximately 24 months
Awards & highlights

DB-08 Trial Summary

This trial will study the safety and effectiveness of a new drug combination in people with metastatic HER2-low breast cancer.

Who is the study for?
This trial is for adults with HER2-low advanced or metastatic breast cancer. Eligible patients must have received certain prior treatments depending on their hormone receptor status, and should not have significant lung disease, uncontrolled infections or illnesses, cardiovascular issues, a history of specific lung conditions, primary immunodeficiency, spinal cord compression or active brain metastases.Check my eligibility
What is being tested?
The DESTINY-Breast 08 study tests the combination of T-DXd (Trastuzumab deruxtecan) with other therapies like Fulvestrant, Durvalumab, Capivasertib, Anastrozole, Paclitaxel and Capecitabine in treating HER2-low advanced/metastatic breast cancer to evaluate safety and early anti-tumor effects.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to treatment components such as inflammation in various organs. Specific side effect profiles will depend on the drug combinations used but can range from mild symptoms like fatigue to more serious conditions.

DB-08 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have HR- breast cancer and have had specific prior treatments depending on the study part.
Select...
If you have hormone receptor-positive breast cancer, for Part 1, you must have had at least one treatment with hormonal therapy, with or without a targeted therapy, and at least one treatment with chemotherapy for metastatic breast cancer. For Part 2, you can have only one prior treatment with hormonal therapy, with or without a targeted therapy, and no prior chemotherapy in the metastatic setting.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My breast cancer is HER2-low, hormone receptor positive, and not responsive to estrogen or progesterone.

DB-08 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to follow-up period, approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to follow-up period, approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of adverse events (AEs)- Part 1
Occurrence of adverse events (AEs)- Part 2
Occurrence of serious adverse events (SAEs)- Part 1
+1 more
Secondary outcome measures
Duration of Response (DoR)- Part 2
Immunogenicity of durvalumab
Immunogenicity of trastuzumab deruxtecan
+5 more

DB-08 Trial Design

5Treatment groups
Experimental Treatment
Group I: Module 5: T-DXd + fulvestrantExperimental Treatment2 Interventions
T-DXd: 5.4 mg/kg Q3W, intravenous use Fulvestrant: 500 mg Q4W, intramuscular use
Group II: Module 4: T-DXd + anastrozoleExperimental Treatment2 Interventions
T-DXd: 5.4 mg/kg Q3W, intravenous use Anastrozole: 1 mg daily, oral
Group III: Module 3: T-DXd + capivasertibExperimental Treatment2 Interventions
T-DXd: 5.4 mg/kg Q3W, intravenous use Capivasertib: 400 mg BID, oral use
Group IV: Module 2: T-DXd + durvalumab + paclitaxelExperimental Treatment3 Interventions
T-DXd: 5.4 mg/kg Q3W, intravenous use Durvalumab: 1120 mg Q3W, intravenous use Paclitaxel: 80 mg/m2 QW in 3-week cycles, intravenous use
Group V: Module 1: T-DXd + capecitabineExperimental Treatment2 Interventions
T-DXd: 5.4 mg/kg Q3W, intravenous use Capecitabine: 1000mg/m2 BID, days 1-14 Q3W, oral use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3700
Trastuzumab deruxtecan
2020
Completed Phase 2
~60
Durvalumab
2017
Completed Phase 2
~3870
Capivasertib
2021
Completed Phase 1
~130
Anastrozole
2019
Completed Phase 4
~10090
Paclitaxel
2011
Completed Phase 4
~5380
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Daiichi Sankyo Company, LimitedUNKNOWN
1 Previous Clinical Trials
245 Total Patients Enrolled
AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,449,682 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
49,090 Total Patients Enrolled
4 Trials studying Breast Cancer
1,942 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04556773 — Phase 1
Breast Cancer Research Study Groups: Module 2: T-DXd + durvalumab + paclitaxel, Module 3: T-DXd + capivasertib, Module 5: T-DXd + fulvestrant, Module 1: T-DXd + capecitabine, Module 4: T-DXd + anastrozole
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT04556773 — Phase 1
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04556773 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Fulvestrant be considered a health risk for those taking it?

"The evaluation of Fulvestrant's safety on a scale from 1-3 yielded an overall score of 1 due to the limited amount of data available regarding its efficacy and security."

Answered by AI

What is the current geographic distribution of this experiment?

"The presented medical trial is enrolling participants at 17 sites, including Commack, Chattanooga and Basking Ridge as well as other cities. To lessen travel time, it would be best to select the most proximate location for you if any involvement in this study transpires."

Answered by AI

How many volunteers have enrolled in this experiment?

"Affirmative. According to the clinicaltrials.gov page, registration for this medical trial began on December 17th 2020 and concluded October 31st 2022. 182 individuals are sought out from a total of 17 enrolment sites."

Answered by AI

Is this clinical research program currently enrolling participants?

"Affirmative. According to the information posted on clinicaltrials.gov, recruitment for this trial is still ongoing; it was initially published in December 17th 2020 and its details were last updated on October 31st 2022. A total of 182 participants must be enrolled from a pool of 17 designated sites."

Answered by AI

Is there precedent for using Fulvestrant as part of a medical investigation?

"Fulvestrant, initially studied in 1997 by the City of Hope Comprehensive Cancer Center, has seen 1958 studies come to completion. Presently 1596 clinical trials are active, many based out of Commack, New york."

Answered by AI

What are the research objectives of this investigation?

"The main objective of this two-year study is to evaluate the occurrence of adverse events associated with durvalumab administration. Secondary endpoints are progression free survival, overall survival, and serum concentration levels of durvalumab over time."

Answered by AI

For what ailments is Fulvestrant typically prescribed?

"Fulvestrant is most commonly deployed to treat non-small cell lung cancer. Additionally, it can be beneficial in treating metastatic bladder cancer, acquired immunodeficiency syndrome, and advanced thymoma cases."

Answered by AI
~33 spots leftby Mar 2025