Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Adenocarcinoma

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Inflammatory Breast Cancer

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Trastuzumab deruxtecan

Durvalumab

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2).

* HER2-positive determined locally by the current ASCO/CAP guidelines
* Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery. (Cycle Length is 21 days)
* After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.

Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2)

* HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
* Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery (Cycle Length is 21 days)
* After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.

via IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).

Filipa Lynce, MD

Rachel Layman, MD

The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.

The names of the study drugs involved in this study are:

* Trastuzumab deruxtecan
* Durvalumab

This is a phase 2 open label study of neoadjuvant trastuzumab deruxtecan plus durvalumab for patients with stage III, HER2-positive or HER2-low inflammatory breast cancer (IBC), who have not received prior therapy for ipsilateral breast cancer.

Participants will be enrolled into one of two study treatment groups: HER2 positive IBC (Cohort 1) or HER2 low IBC (Cohort 2).

Research procedures including screening for eligibility, clinic visits for treatment, tumor biopsies, and blood tests.

The U.S. Food and Drug Administration (FDA) has not approved Durvalamab or Trastuzumab deruxtecan for inflammatory breast cancer, but both have been approved for other uses.

Participation in this study is expected to last about 22 months.

It is expected that about 63 people will take part in this research study.

The pharmaceutical company, AstraZeneca, is supporting this research study by providing the study drugs and funding.

TRUDI: TDXD+Durva in HER2+/Low IBC

TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

pCR rate is the proportion of participants with absent invasive carcinoma in the breast and lymph nodes at time of surgery; in situ disease only is considered pCR; if off-treatment prior to surgery than considered not pCR.

RCB response is the number of participants by RCB category; the RCB calculator used is from M.D Anderson with parameters (see References for link).

EFS defined from the time of registration until the occurrence of the first of the following events:

* Progression of disease that precludes surgery;
* Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast;
* Contralateral invasive breast cancer;
* Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; or
* Death from any cause. In the absence of an event, EFS is censored at date last disease assessment. t-year EFS to be estimated by Kaplan-Meier method, with time "t" specified according to median follow-up at time of reporting.

DP/DDFS defined from the time of registration until the occurrence of the first of the following events:

* Distant progression of disease prior to surgery;
* Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; or
* Death from any cause. In the absence of an event, DP/DDFS is censored at date last disease assessment. t-year DP/DDFS to be estimated by Kaplan-Meier method, with time "t" specified according to median follow-up at time of reporting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TRUDI: TDXD+Durva in HER2+/Low IBC	NCT05795101	Invasive Breast... Inflammatory Br... HER2-positive B... HER2 Low Breast... Breast Cancer	Trastuzumab der... Durvalumab	18 Years -	Dana-Farber Cancer Institute
TRUDI: TDXD+Durva in HER2+/Low IBC	NCT05795101	Invasive Breast... Inflammatory Br... HER2-positive B... HER2 Low Breast... Breast Cancer	Trastuzumab der... Durvalumab	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for her2 low breast adenocarcinoma