Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04419181
• Other study ID #: UBRS20013
• Status: Suspended
• Phase: Phase 2
• Start date: August 11, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: October 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Docetaxel
Dose: 75 mg/m2 q3w
• Carboplatin
Dose: area under the concentration-time curve [AUC] 6 q3w
• Trastuzumab
Dose: 8-mg/kg loading dose, 6-mg/kg maintenance dose q3w
• Pertuzumab
Dose: 840-mg loading dose, 420-mg maintenance dose q3w
• Trastuzumab emtansine
Dose: 3.6mg/kg q3w

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One Year Invasive Disease-Free Survival	The study will be considered feasible if the researchers observe the invasive disease free survival (IDFS) estimate at one year to be 90% or more among those who achieved a pCR, or if the researchers observe the IDFS estimate at one year to be 85% or more among those who had residual disease.	One year from the breast cancer surgery
Secondary	Pathologic Complete Response rate	Assess the pCR rate after four cycles (12 weeks) of TCHP.	12 weeks from start of treatment
Secondary	Toxicity of chemo and HER2 therapies	Evaluate toxicity associated with neoadjuvant and adjuvant chemo and/or HER2 directed therapies. Percentage of grade 1 to grade 5 toxicities will be assessed during the neo-adjuvant TCHP therapy for all participants. Percentage of grade 1 to grade 5 toxicities will be assessed with adjuvant trastuzumab therapy for the cohort with pathological complete response, and with optional adjuvant TCHP therapy and adjuvant TDM1 + pertuzumab therapy for the residual disease cohort. Toxicity data will be obtained based on the clinical assessment of the participants by the investigators and based on laboratory data.	One year from the start of treatment
Secondary	Two Year Invasive Disease-Free Survival	Two year invasive disease-free survival (IDFS) of participants with pCR and participants with residual disease	Two years from the breast cancer surgery