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Breast cancer shot could replace lengthy IV drips

NCT ID NCT04024462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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