Breast CancerPhase 2NCT07884201
Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment
A Phase 2 study testing Thymalfasin in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Fudan University.
Trial summary
This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T > 2 cm, N+). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy
- What is being tested?
- Thymalfasin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2026to 8 Oct 2031
- Phase
- Phase 2
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- Female aged 18 to 70 years;
- Histologically confirmed unilateral primary invasive breast cancer, planned to undergo neoadjuvant therapy (chemotherapy or at least 6 cycles of ADC therapy combined with immunotherapy);
- Immunohistochemistry (IHC) confirmed triple-negative breast cancer (ER <1%, PR <1%, HER-2 0, or 1, or 2 with FISH negative);
- At least one measurable lesion according to RECIST 1.1 criteria;
- Major organ function essentially normal, meeting the following conditions:
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- Hematology criteria: HB ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10^9/L; PLT ≥75×10^9/L;
- Biochemistry criteria: TBIL ≤1.5×ULN; ALT and AST ≤3×ULN; serum creatinine ≤1.5×ULN; estimated creatinine clearance >50 ml/min (Cockcroft-Gault formula);
- ECOG performance status of 0-1;
- LVEF ≥55%;
- Female subjects of childbearing potential must use at least one medically recognized method of contraception during the study treatment and for at least 3 months after the last dose of the study drug;
- Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Patients with any of the following conditions are not eligible to participate in this study:
- Patients who have previously received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason;
- Patients with heart disease classified as New York Heart Association (NYHA) class II or higher (including class II);
- Patients with severe systemic infections or other serious illnesses;
- Patients known to be allergic to or intolerant of the study drug or its excipients;
- Patients who have had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer;
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- Pregnant or breastfeeding women, as well as women of childbearing potential who refuse to use appropriate contraceptive measures during the study;
- Patients who have previously undergone organ transplantation;
- Patients deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thymalfasin Combined With Chemotherapy and Immunotherapy for Neoadjuvant Treatment of Triple-Negative Breast Cancer：A Prospective, Open-Label, Single-Center, Phase II, Randomized Controlled Clinical Study
This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T > 2 cm, N+). The study aims to further validate the sensitizing effect and safety of Thymalfasin in combination with neoadjuvant chemotherapy and immunotherapy by comparing the 3-year event-free survival (EFS) and IFNγ elevation rates between the group receiving Thymalfasin in combinatione with standard neoadjuvant chemotherapy and immunotherapy and the control group receiving standard neoadjuvant chemotherapy and immunotherapy alone.
- Being tested
- Thymalfasin
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymalfasinDrug
Thymalfasin 1.6 mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Thymalfasin Arm | Experimental | Not described Receives: Drug: Thymalfasin |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS
From randomization to the occurrence of any predefined event (such as disease progression, relapse, death, discontinuation due to toxicity, or change of treatment regimen)
Measured: 3 years
Interferon-gamma (IFNγ) elevation rate
IFNγ Increase Rate = (Preoperative Serum IFNγ - Baseline Serum IFNγ) / Baseline Serum IFNγ × 100%
Measured: 3 years
Secondary outcomes (3)
pCR
Pathological Complete Response Rate
Measured: 3 years
OS
Overall survival is defined as the time from randomization to death from any reason
Measured: 3 years
Safety
Assess the safety of the treatment according to CTCAE 5.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start8 Nov 2026 (estimated)
- Primary completion7 Nov 2029 (estimated)
- Study completion8 Oct 2031 (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 Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keda Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884201
- Sponsor's protocol ID
- TITAN
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No