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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04569747




Registration number
NCT04569747
Ethics application status
Date submitted
25/09/2020
Date registered
30/09/2020

Titles & IDs
Public 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
Scientific title
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)
Secondary ID [1] 0 0
20-347
Universal Trial Number (UTN)
Trial acronym
ADEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-positive Breast Cancer 0 0
Invasive Carcinoma of the Breast 0 0
Breast Cancer 0 0
Node Negative Breast Cancer 0 0
Micrometastasis Breast Cancer 0 0
Hormone Receptor Positive Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pertuzumab+TRASTUZUMAB
Treatment: Drugs - ADJUVANT ENDOCRINE THERAPY

Experimental: PERTUZUMAB + TRASTUZUMAB + ADJUVANT ENDOCRINE THERAPY - Study 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)


Other interventions: Pertuzumab+TRASTUZUMAB
Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose

Treatment: Drugs: ADJUVANT ENDOCRINE THERAPY
Oral, daily per cycle
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival at 3 Years
Timepoint [1] 0 0
3 Years
Secondary outcome [1] 0 0
Invasive Disease Free Survival at 7 Years
Timepoint [1] 0 0
7 years
Secondary outcome [2] 0 0
Invasive Disease Free Survival at 10 Years
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Recurrence-free interval (RFI) at 3 Years
Timepoint [3] 0 0
3 Years
Secondary outcome [4] 0 0
Recurrence-free interval (RFI) at 7 Years
Timepoint [4] 0 0
7 Years
Secondary outcome [5] 0 0
Recurrence-free interval (RFI) at 10 Years
Timepoint [5] 0 0
10 Years
Secondary outcome [6] 0 0
Breast cancer-specific survival (BCSS) at 3 Years
Timepoint [6] 0 0
3 Years
Secondary outcome [7] 0 0
Breast cancer-specific survival (BCSS) at 7 Years
Timepoint [7] 0 0
7 Years
Secondary outcome [8] 0 0
Breast cancer-specific survival (BCSS) at 10 Years
Timepoint [8] 0 0
10 Years
Secondary outcome [9] 0 0
Overall survival
Timepoint [9] 0 0
randomization and death. Surviving patients classified as lost-to-follow-up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first up to 10 years
Secondary outcome [10] 0 0
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [10] 0 0
baseline to 5 Years
Secondary outcome [11] 0 0
Total patient chair time of drug administration
Timepoint [11] 0 0
baseline to 18 Months

Eligibility
Key inclusion criteria
* 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.
* Patients who have participated in a window study (treatment with an investigational agent prior to surgery for =2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation in this study.
* Men and women with any menopausal status =18 years of age
* ECOG Performance Status 0 or 1
* Participants must have normal organ and marrow function as defined below:

* ANC = 1000/mm3
* hemoglobin =8 g/dl
* platelets = 75,000/mm3
* AST and ALT both <5x institutional ULN
* Total bilirubin = 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be <institutional ULN
* Serum creatinine = 2.0 mg/dL OR calculated GFR = 30mL/min
* Left ventricular ejection fraction (LVEF) = 50%
* Post-menopausal patients must meet one of the following criteria:

* Prior bilateral ovariectomy/oophorectomy
* Age = 60 years
* Age < 60 years with intact uterus and amenorrhoeic for = 12 consecutive months prior to chemotherapy and/or endocrine therapy exposure (medication-induced amenorrhea is not acceptable to meet this criterion)
* Age < 60 years hysterectomized and FSH and plasma estradiol levels in the postmenopausal range according to local policies prior to chemotherapy and/or endocrine therapy exposure.
* Willingness to discontinue contraceptive hormonal therapy, e.g. birth control pills, prior to registration and while on study
* Premenopausal patients with intact uterus must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and women less than 12 months from their last menstrual period.
* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of antibody treatment and 3 months after the last dose of hormonal treatment.
* Patients must be willing and able to sign informed consent.
* Patients must be willing to provide archival tissue for research purposes.
* If patient is English-speaking, must be willing to fill out patient questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.

Time and Motion Substudy Eligibility:

* Participant must be enrolled at Dana-Farber Cancer Institute
* Participant must not have discontinued pertuzumab following treatment cycle 1
* Participant must be able to tolerate subcutaneous administration following cycle 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2030
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maine
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
Dana-Farber Cancer Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adrienne C Waks, MD
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adrienne Waks, MD
Address 0 0
Country 0 0
Phone 0 0
617-632-3800
Fax 0 0
Email 0 0
awaks@partners.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Data can be shared no earlier than 1 year following the date of publication
Available to whom?
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04569747