Breast CancerPhase 1ColBreastNCT06725082
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery
A Phase 1 study testing Recombinant Humanized Type III Collagen Injection in people with Breast Cancer and Collagen Protein, run by Peking University People's Hospital at 1 site in China.
Trial summary
Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Collagen Protein
- What is being tested?
- Recombinant Humanized Type III Collagen Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 years or older but not exceeding 80 years;
- Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
- Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
- No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
- ECOG Performance Status (PS) - 0 or 1;
- Subjects voluntarily join this study and sign the informed consent form.
Who cannot join
- a.Tumor-related symptoms and treatments
- 1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, China, 100044
Mengmeng Zhang, 86-18800197038, zhangmm428@163.com
About this study
Official title: Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol
Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.
- Conditions
- Breast Cancer, Collagen Protein
- Being tested
- Recombinant Humanized Type III Collagen Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Type III Collagen InjectionBiological
rhCOL3/saline will be injected around the tumor (at four points: outer upper, inner upper, outer lower, and inner lower) before surgery, with 500ul per site. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision), followed by routine tissue flap revision and suture.
| Study group | Role | What they receive |
|---|---|---|
| rhCOL3 Injection Group | Experimental | RhCOL3 will be prepared as a 4mg/ml and injected around the tumor. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision). Receives: Biological: Recombinant Humanized Type III Collagen Injection |
| Control Group | Placebo comparator | 4ml of saline will be injected around the tumor before surgery. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, 2ml of saline will be injected around the breast surgical area skin. Receives: Biological: Recombinant Humanized Type III Collagen Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term postoperative complications after surgery and radiotherapy.
The purpose of this study is to assess the incidence rate of short-term complications within 3 months after patients complete surgery and radiotherapy. The main complications are defined as surgery or radiotherapy-related complications occurring during postoperative follow-up, including delayed wound healing, partial skin necrosis, infection, and hematoma and seroma; common adverse reactions related to breast radiotherapy include acute radiation dermatitis, breast edema, pain, etc., and late-stage breast fibrosis, edema, atrophy, telangiectasia, etc.
Measured: 3 month
Secondary outcomes (1)
Changes in clinical pathological indicators
For patients undergoing breast tumor surgery, observe changes in immune cell infiltration (CD4, CD8, FoxP3, CD80, CD206, etc.), fibroblast activation (FAP, α-SMA, S100a4, etc.), extracellular matrix remodeling (COL3A1, COL1A1), and cancer cell activation status (ki-67, P27, etc.) in postoperative pathological tissue to assess the impact of rhCOL3 on the tumor microenvironment.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725082
- Sponsor's protocol ID
- PKUPH2024PHD011-001
- Acronym
- ColBreast
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06725082
- Acronym / sponsor ID
- ColBreast / PKUPH2024PHD011-001
- Conditions
- Breast Cancer, Collagen Protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhCOL3 Injection Group | Experimental | Biological: Recombinant Humanized Type III Collagen InjectionRhCOL3 will be prepared as a 4mg/ml and injected around the tumor. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision). |
| Control Group | Placebo comparator | Biological: Recombinant Humanized Type III Collagen Injection4ml of saline will be injected around the tumor before surgery. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, 2ml of saline will be injected around the breast surgical area skin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females aged 18 years or older but not exceeding 80 years;
- Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
- Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
- No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
- ECOG Performance Status (PS) - 0 or 1;
Key exclusion criteria (2 listed)
- a.Tumor-related symptoms and treatments
- 1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Humanized Type III Collagen InjectionrhCOL3/saline will be injected around the tumor (at four points: outer upper, inner upper, outer lower, and inner lower) before surgery, with 500ul per site. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision), followed by routine tissue flap revision and suture. | Biological | Control Group, rhCOL3 Injection Group |
Primary outcome
Short-term postoperative complications after surgery and radiotherapy.
Time frame: 3 month
The purpose of this study is to assess the incidence rate of short-term complications within 3 months after patients complete surgery and radiotherapy. The main complications are defined as surgery or radiotherapy-related complications occurring during postoperative follow-up, including delayed wound healing, partial skin necrosis, infection, and hematoma and seroma; common adverse reactions related to breast radiotherapy include acute radiation dermatitis, breast edema, pain, etc., and late-stage breast fibrosis, edema, atrophy, telangiectasia, etc.
1 secondary outcome
Changes in clinical pathological indicators
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Humanized Type III Collagen Injection in people with Breast Cancer and Collagen Protein, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengmeng Zhang (86-18800197038, zhangmm428@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term postoperative complications after surgery and radiotherapy. (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.