Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Trastuzumab deruxtecan

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Mitogens

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Immunoconjugates

doxorubicin and cyclophosphamide, followed by THP

Trastuzumab Deruxtecan

cyclophosphamide

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy.

Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

Participants are assigned to one of three arms in parallel for the duration of the study.

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Qualified researchers can request access to anonymized individual patient data from AstraZeneca Group of Companies, sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ Disclosure Commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Proportion of participants who have no evidence by H\&E staining of residual invasive disease

Daiichi Sankyo

AstraZeneca

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Itraconazole

Carbamazepine

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Analgesics, Non-Narcotic

Sodium Channel Blockers

Diuretics, Potassium Sparing

Participant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11.

Participant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15.

BAY2927088

Bayer Clinical Trials Contact

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.

Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.

In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.

BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.

BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.

The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine

* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood

The study will have 2 treatment groups.

In Group 1, participants will take:

* BAY2927088 as a single dose on Days 1 and 8.
* Itraconazole once daily on Days 5 to 11.

In Group 2, participants will take:

* BAY2927088 as a single dose on Days 1 and 14.
* Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up

During the study, the doctors and their study team will:

* perform physical examinations
* collect blood samples from the participants to measure the levels of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants

A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer	NCT05113251	Breast Neoplasm... Breast Cancer HER2-positive E...	Trastuzumab Der... Paclitaxel Trastuzumab Pertuzumab Doxorubicin cyclophosphamid...	18 Years -	AstraZeneca
A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants	NCT06348888	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Itraconazole Carbamazepine	18 Years - 55 Years	Bayer

Spots Global Cancer Trial Database for her2 (human epidermal growth factor receptor 2)