A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
ADEPT
20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT)
1 other identifier
interventional
393
1 country
32
Brief Summary
This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are:
- A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO)
- Hormonal (endocrine) Treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedStudy Start
First participant enrolled
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
ExpectedApril 2, 2026
March 1, 2026
5.2 years
September 25, 2020
March 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasive Disease Free Survival at 3 Years
Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals. from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause
3 Years
Secondary Outcomes (11)
Invasive Disease Free Survival at 7 Years
7 years
Invasive Disease Free Survival at 10 Years
10 years
Recurrence-free interval (RFI) at 3 Years
3 Years
Recurrence-free interval (RFI) at 7 Years
7 Years
Recurrence-free interval (RFI) at 10 Years
10 Years
- +6 more secondary outcomes
Other Outcomes (9)
Patient-reported hormonal therapy adherence
5 years
FACT B
baseline to 18 Months
Rotterdam symptom checklist,
baseline to 18 Months
- +6 more other outcomes
Study Arms (1)
PERTUZUMAB + TRASTUZUMAB + ADJUVANT ENDOCRINE THERAPY
EXPERIMENTALStudy treatment will be administered in 21-day (3- week, +/- 3 days) cycles for one year (18 cycles). * Trastuzumab + Pertuzumab SC fixed dose combination * Hormonal therapy- oral, daily per cycle (may add LHRH agonist per investigator discretion)
Interventions
Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose
Oral, daily per cycle
Eligibility Criteria
You may qualify if:
- HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table.
- If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative.
- Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the Sponsor-Investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
- Patients who have one or more foci of T1aN0, ER+ (defined as \>10%), HER2-negative cancer in the ipsilateral breast, in addition to their primary HER2-positive tumor, are eligible.
- For unifocal disease, all invasive disease must have been tested for ER and PR (for multifocal disease, see below). Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
- HER2-positive by ASCO CAP 2018 guidelines.
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
- Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria.
- Patients with a history of ipsilateral DCIS are eligible as long as the patient has not received prior hormonal therapy. Patients with a history of contralateral DCIS are not eligible unless contralateral DCIS was diagnosed at least 15 years ago
- ≤ 95 days between the date of protocol registration and the patient's most recent breast surgery for this breast cancer
- Patients must have undergone definitive breast surgery for the current malignancy. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
- \-- All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed. Radiation therapy to the conserved breast is required.
- Patients may have received up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer. Patients should otherwise not have received prior hormonal therapy with the exception that hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed.
- Prior oophorectomy (including for cancer therapy) is allowed.
- Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
- +22 more criteria
You may not qualify if:
- Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
- Any of the following due to teratogenic potential of the study drugs:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted.
- Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc).
- Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator.
- Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
- Patients with a history of previous invasive breast cancer.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances:
- Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
- individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.
- Time and Motion Substudy Eligibility:
- Participant must be enrolled at Dana-Farber Cancer Institute
- Participant must not have discontinued pertuzumab following treatment cycle 1
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Genentech, Inc.collaborator
Study Sites (32)
Stamford Hospital
Stamford, Connecticut, 06904, United States
University of Miami- Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Winship Cancer Institute at Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University Health Schwarz Cancer Center
Indianapolis, Indiana, 46032, United States
Indiana University Health - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Indiana University Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, 04412, United States
Dana Farber Cancer Institite
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035, United States
Cape Cod Healthcare Center
Hyannis, Massachusetts, 02601, United States
Dana-Farber at Milford
Milford, Massachusetts, 01757, United States
Dana-Farber at South Shore Hospital
Weymouth, Massachusetts, 02190, United States
Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire, 03053, United States
New York University Langone Hospital -Brooklyn
Brooklyn, New York, 11220, United States
New York University Langone Hospital - Long Island
Mineola, New York, 11501, United States
New York University Langone Health
New York, New York, 10016, United States
UNC Rex Hematology Oncology Associated - Cary
Cary, North Carolina, 27518, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
UNC Rex Hematology Oncology Associates of Garner
Garner, North Carolina, 27529, United States
UNC Rex Cancer Center
Raleigh, North Carolina, 27607, United States
UNC Rex Cancer Center at Wakefield
Raleigh, North Carolina, 27614, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Greco-Hainsworth Centers for Research/Tennessee Oncology
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Waks AG, Chen EL, Graham N, Frey AM, Almeida K, Attaya V, Ryding C, Abbass I, Fung A, Sussell J, Cortazar P, Harvey C, Leth D, Faggen M, Sinclair N, Walsh J, Tung N, Sinclair S, Lo S, Yardley D, Valero V, Meisel J, Ballinger TJ, Adams S, Carey LA, Rauch JK, Abramson VG, Williams NO, Chen WY, Leone JP, Schumer ST, Tayob N, Tolaney SM. Subcutaneous vs Intravenous Trastuzumab/Pertuzumab: A Time and Motion Substudy of a Phase II Trial of Adjuvant Trastuzumab/Pertuzumab for Stage I HER2+ Breast Cancer (ADEPT trial). JCO Oncol Pract. 2025 Mar;21(3):351-357. doi: 10.1200/OP.24.00021. Epub 2024 Jul 19.
PMID: 39028923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrienne C Waks, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
September 25, 2020
First Posted
September 30, 2020
Study Start
January 11, 2021
Primary Completion
March 23, 2026
Study Completion (Estimated)
September 1, 2030
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.