Breast cancer shot could replace lengthy IV drips
NCT ID NCT04024462
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 3 trial tested whether a fixed-dose combination of two targeted drugs (pertuzumab and trastuzumab) given as a simple shot under the skin works as well as the standard IV infusion in 200 Chinese patients with HER2-positive early breast cancer. The study measured drug levels in the blood and checked how many patients had no cancer left after treatment. If the shot works, it could save patients time and make treatment more comfortable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pertuzumab and trastuzumab fixed-dose combination for subcutaneous injection (PH FDC SC)
- What this could lead to
- If successful, this could offer a more convenient, faster subcutaneous injection option instead of lengthy IV infusions for HER2-positive early breast cancer patients.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to other populations or stages. The main focus is on drug levels in the blood, not long-term cure rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
200 people
The number who actually took part.
- Started
-
Feb 2020
- Finished
-
Jan 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to comply with the study protocol, in the investigator's judgment * Eastern Cooperative Oncology Group (ECOG) Performance Status greater or equal to (≤)1 * Stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer * Primary tumor greater than (\>)2 centimeters (cm) in diameter, or node-positive disease (clinically or on imaging, and node positivity confirmed with cytology and/or histopathology) * Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material and defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies * Hormone receptor status of the primary tumor, centrally confirmed * Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy * Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue for central confirmation of HER2, hormone receptor status, and PIK3CA mutational analyses * Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent (refrain from heterosexual intercourse) or use one highly effective non-hormonal contraceptive method with a failure rate of less than (\<)1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom in combination with a spermicidal foam, gel, film, cream, or suppository, and agreement to refrain from donating sperm, as specified in the protocol * A negative serum pregnancy test must be available prior to randomization for WOCBP (premenopausal women and women \<12 months after the onset of menopause), unless they have undergone surgical sterilization (removal of ovaries and/or uterus) * No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment Exclusion Criteria: * Stage IV (metastatic) breast cancer * History of invasive breast cancer * History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin * Have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy \[selective estrogen receptor modulators, aromatase inhibitors\], and antitumor vaccines) for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer * Have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast * High-risk for breast cancer and have received chemopreventative drugs in the past * Multicentric (multiple tumors involving more than one quadrant) breast cancer, unless all tumors are HER2-positive * Bilateral breast cancer * Have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes * Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy * Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy * Treatment with any investigational drug within 28 days prior to randomization * Serious cardiac illness or medical conditions * Inadequate bone marrow function * Impaired liver function * Inadequate renal function with serum creatinine \>1.5X upper limit of normal (ULN) * Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders) * Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * Known active liver disease, for example, active viral hepatitis infection (i.e., hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis * Concurrent, serious, uncontrolled infections, or known infection with HIV * Known hypersensitivity to study drugs, excipients, and/or murine proteins * Current chronic daily treatment with corticosteroids (dose \>10 milligrams \[mg\] methylprednisolone or equivalent excluding inhaled steroids) * History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe LVSD, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive early breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Cancer Hospital
Beijing, 100142, China
-
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
-
Harbin Medical University Cancer Hospital
Harbin, 150081, China
-
Hebei Medical University Fourth Hospital
Shijiazhuang, 050035, China
-
Hubei Cancer Hospital
Wuhan, 430079, China
-
Jiangsu Province Hospital
Nanjing, 210036, China
-
Jilin Cancer Hospital
Changchun, 130012, China
-
Peking University People's Hospital
Beijing, 100044, China
-
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
-
Shandong Cancer Hospital
Jinan, 250117, China
-
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
-
The 900th Hospital of PLA joint service support force
Fuzhou, 110016, China
-
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003, China
-
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
-
The First Hospital of Jilin University
Changchun, 130021, China
-
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430023, China
-
West China Hospital, Sichuan University
Chengdu, 610041, China
-
Zhejiang Cancer Hospital
Hangzhou, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New PET scan may tell doctors if chemo wiped out breast cancer without surgery
- New breast cancer trial adapts treatment based on early response
- New pill combo aims to wipe out breast tumors before surgery
- Could a Chemo-Free cocktail beat early breast cancer?
- New drug combo aims to wipe out aggressive breast cancer before surgery
- New drug combo could spare chemo for some breast cancer patients