Trial Filter
BETAAn intelligent search tool for clinical trials
Official 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)
Phase
Phase 2
Sponsor
Dana-Farber Cancer Institute
Enrollment
375
Timeline
Jan 2021 → Sep 2030
About This Study
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
Eligibility Criteria
Inclusion Criteria
- 1HER2-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.
- 2If 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.
- 3Any 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.
- 4Patients 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.
- 5For 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.
- 6HER2-positive by ASCO CAP 2018 guidelines.
- 7Bilateral breast cancers that individually meet eligibility criteria are allowed.
- 8Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria.
- 9Patients 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
- 10≤ 95 days between the date of protocol registration and the patient's most recent breast surgery for this breast cancer
- 11Patients 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
- 12\-- 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.
- 13Patients 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.
- 14Prior oophorectomy (including for cancer therapy) is allowed.
- 15Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
- 16Patients 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.
- 17Men and women with any menopausal status ≥18 years of age
- 18ECOG Performance Status 0 or 1
- 19Participants must have normal organ and marrow function as defined below:
- 20ANC ≥ 1000/mm3
- 21hemoglobin ≥8 g/dl
- 22platelets ≥ 75,000/mm3
- 23AST and ALT both \<5x institutional ULN
- 24Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be \<institutional ULN
- 25Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min
- 26Left ventricular ejection fraction (LVEF) ≥ 50%
- 27Post-menopausal patients must meet one of the following criteria:
- 28Prior bilateral ovariectomy/oophorectomy
- 29Age ≥ 60 years
- 30Age \< 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)
- 31Age \< 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.
- 32Willingness to discontinue contraceptive hormonal therapy, e.g. birth control pills, prior to registration and while on study
- 33Premenopausal 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.
- 34Women 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.
- 35Patients must be willing and able to sign informed consent.
- 36Patients must be willing to provide archival tissue for research purposes.
- 37If patient is English-speaking, must be willing to fill out patient questionnaires.
Exclusion Criteria
- 1Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
- 2Any of the following due to teratogenic potential of the study drugs:
- 3Pregnant women
- 4Nursing women
- 5Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted.
- 6Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc).
- 7Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator.
- 8Locally 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)
- 9Patients with a history of previous invasive breast cancer.
- 10Individuals with a history of a different malignancy are ineligible except for the following circumstances:
- 11Individuals 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.
- 12individuals 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.
- 13Intercurrent 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.
- 14Time and Motion Substudy Eligibility:
- 15Participant must be enrolled at Dana-Farber Cancer Institute
- 16Participant must not have discontinued pertuzumab following treatment cycle 1
- 17Participant must be able to tolerate subcutaneous administration following cycle 1
Locations
32 sites participating in this study
Winship Cancer Institute at Emory University Hospital Midtown
Atlanta, Georgia 30308
Jane Meisel, MD
Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
Jane Meisel, MD
Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Jane Meisel, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →