Clinical trial NCT04419181: Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
Official title: A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive Breast Cancer
De-escalation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to an arm of the trial based on their outcomes after surgery.
Primary purpose: TREATMENT

Brief summary: The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Detailed description: Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.

Eligibility criteria: Inclusion Criteria:

* Women ≥18 years of age
* Biopsy proven HER2+ early breast cancer
* ECOG performance status 0-1
* Should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease.
* Adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion.
* Women of childbearing potential who are sexually active must agree to use highly effective methods of contraception during treatment and for three weeks after the last dose of chemotherapy or anti-HER2 therapy. The women currently using hormonal contraceptives must agree to change to an alternative highly effective method of contraception
* Willingness and ability to comply with study and follow-up procedures and give written informed consent.

Exclusion Criteria:

* Any evidence of stage IV breast cancer
* Participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved
* Any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: One Year Invasive Disease-Free Survival
timeFrame: One year from the breast cancer surgery
Secondary outcomes:
measure: Pathologic Complete Response rate
timeFrame: 12 weeks from start of treatment
measure: Toxicity of chemo and HER2 therapies
timeFrame: One year from the start of treatment
measure: Two Year Invasive Disease-Free Survival
timeFrame: Two years from the breast cancer surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Ajay Dhakal, MBBS
role: PRINCIPAL_INVESTIGATOR
References: