New drug cocktail aims to wipe out breast cancer before surgery
NCT ID NCT06891833
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests a new drug called BL-M07D1, given alone or with pertuzumab, against the standard treatment (taxane + trastuzumab and pertuzumab) for HER2-positive breast cancer before surgery. About 120 women with stage II-III breast cancer will participate. The goal is to see if the new approach leads to a complete disappearance of cancer in the breast tissue at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-M07D1 (a drug given by IV) and pertuzumab (another drug given by IV)
- What this could lead to
- If successful, this could offer a more effective pre-surgery treatment option for HER2-positive breast cancer, potentially improving the chance of a complete response.
- What could go wrong
- This is an early-to-mid stage trial with only 120 participants, so results may not apply to everyone. The new drug combination may not work better than standard therapy and could have unknown side effects.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 985 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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: 1. Voluntarily signed informed consent and followed the program requirements; 2. Females ≥18 and ≤75 years of age at the time of signing the informed consent; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histologic examination; 5. Clear hormone receptor (HR) status; 6. Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy; 7. Primary subjects without antitumor therapy for breast cancer; 8. Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy; 9. Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart; 10. Physical status score ECOG 0 or 1; 11. Organ function levels must be met provided that blood transfusions are not permitted within 14 days prior to the first administration of study drug, colony-stimulating factors are not permitted, and so on; 12. For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients should be using adequate and highly effective contraception throughout the treatment cycle and for 7 months after completion of treatment. Exclusion Criteria: 1. Diagnosis of stage IV metastatic breast cancer; 2. Bilateral breast cancer; 3. Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS); 4. Diagnosis of another primary malignancy within 5 years prior to first dose; 5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening; 6. Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias; 7. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg); 8. Complicated lung disease resulting in severely impaired lung function; 9. History of ILD / interstitial pneumonitis requiring steroid hormone therapy, current ILD / interstitial pneumonitis, or suspected of having such a disease, etc; 10. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection; 11. Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening; 12. Ongoing treatment with \>10 mg/d prednisone systemic corticosteroid therapy or equivalent anti-inflammatory active drug or any form of immunosuppressive therapy within 2 weeks prior to the first dose; 13. Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies; 14. Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab); 15. Have a history of autologous or allogeneic stem cell transplantation or organ transplantation; 16. Suffering from severe neurological or psychiatric disorders; 17. Subjects with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to signing the information; 18. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea; 19. Subjects who are scheduled to receive a live vaccine or who have received a live vaccine within 28 days prior to the first dose; 20. Presence of other serious physical, laboratory test abnormalities or poor compliance that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
30 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Cancer Hospital
NOT_YET_RECRUITINGHefei, Anhui, China
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Anyang Cancer Hospital
NOT_YET_RECRUITINGAnyang, Henan, China
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Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
NOT_YET_RECRUITINGShenzhen, Guangdong, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
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Fujian Medical University Union Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
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Guangdong Maternal and Child Health Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, China
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Hainan General Hospital
NOT_YET_RECRUITINGHaikou, Hainan, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, China
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Henan Provincial People's Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, China
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Liuzhou People's Hospital
NOT_YET_RECRUITINGLiuzhou, Guangxi, China
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Shaanxi Provincial People's Hospital
NOT_YET_RECRUITINGXi'an, Shaanxi, China
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Shandong Cancer Hospital
NOT_YET_RECRUITINGJinan, Shandong, China
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
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Shanxi Cancer Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
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Sichuan Cancer Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Bengbu Medical University
NOT_YET_RECRUITINGBengbu, Anhui, China
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The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, China
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The First Affiliated Hospital of Henan University of science and technology
NOT_YET_RECRUITINGLuoyang, Henan, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
NOT_YET_RECRUITINGHefei, Anhui, China
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The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, Shaanxi, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
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The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
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Tianjin Cancer Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Xingtai People's Hospital
NOT_YET_RECRUITINGXingtai, Hebei, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?
- Can a PI3K inhibitor boost presurgery breast cancer treatment?
- Can a platform trial match the right drug combo to each tumor?
- Can a shorter treatment hold off small HER2-Positive breast cancers?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?