DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (NCT05504707) | Clinical Trial Compass
RecruitingPhase 1
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
United States30 participantsStarted 2022-08-26
Plain-language summary
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* A diagnosis of HER2-negative breast cancer.
* Diagnosis of HR negative or HR low positive tumor.
* Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
* Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
* Age ≥18 years.
* ECOG performance status 0 or 1.
* Patients must have normal organ and marrow function, as defined below, within 14 days of registration:
* \*Absolute neutrophil count (ANC) ≥ 1500/μL
* \*Platelets ≥ 75 000/μL
* \*Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL
* \*AST/ALT ≤ 3 x institutional ULN
* \*Creatinine ≤ 1.5 x institutional ULN
* Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan).
* Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have …
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: 4 weeks after start of treatment
Trial details
NCT IDNCT05504707
SponsorH. Lee Moffitt Cancer Center and Research Institute