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Breast CancerPhase 2NCT04303988

A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

A Phase 2 study testing SHR-1316, Bevacizumab and Cisplatin/Carboplatin in people with Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Cancer
What is being tested?
SHR-1316, Bevacizumab and Cisplatin/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
30 Mar 2020to 30 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, and ≤ 70 years old, both genders;
  • ECOG performance status 0-2;
  • Pathological tests confirm HR-negative / HER2-negative breast cancer; there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is <1%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);
  • It is required that no platinum drugs have been used before, or platinum drugs have been used (cisplatin/carboplatin only one regimen) and platinum sensitive: no progression during at least 4 cycles of treatment, more than 3 months period between last platinum regimen and the progression of disease；
  • MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；
  • Mannitol or steroid hormone therapy is allowed before enrollment, but the dose of steroid hormone should be stable for at least one week;
  • Adequate function of major organs meets the following requirements:
  • (1)Blood routine ANC≥1.5×109/L； PLT≥75×109/L； Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation: INR≤1.5，APTT≤1.5×ULN, PT does not exceed the upper limit of normal (3)Blood biochemistry TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval <470msec and males <450ms; 8.Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.

Who cannot join

  • Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture.
  • Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
  • Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment. Has received prior therapy with Targeted therapy or Endocrine therapy within the previous week；
  • Subjects with HR-/HER2- who has received prior therapy with bevacizumab or PD-1/PD-L1；
  • Participation in any other clinical trials within 2 weeks of enrollment；
  • Concurrent use of any other Anti-cancer drugs；
Show all 14Show fewer
  • Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma；
  • History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study;
  • History of allergy or hypersensitivity to any of the study drugs or study drug components；
  • History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation；
  • A clear history of neurological or mental disorders, including epilepsy or dementia；
  • Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation；
  • According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)；
  • Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.

Trial locations and contacts

1 site in 1 country.

Jian Zhang, MD contact

13918273761

syner2000@163.com

Ting Li, MD contact

13917792964

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jian Zhang, MD, 86 21 64175590, syner2000@163.com

    Ting Li, MD, 86 21 64175590, cinderellaliting@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-arm, Single-center, Phase II Clinical Study of Triple-negative Breast Cancer Brain Metastases

Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.

Read the detailed description

This is a prospective, single-arm, single-center, Simon's two-stage design, phase II clinical trial in triple-negative breast cancer brain metastases patients. Subjects will receive bevacizumab，SHR1316 combined with cisplatin/carboplatin，and will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, or investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.

Conditions
Breast Cancer
Being tested
SHR-1316, Bevacizumab, Cisplatin/Carboplatin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1316Drug

    Also called HTI-1088

    IV

  • BevacizumabDrug

    Also called Avastin

    IV

  • Cisplatin/CarboplatinDrug

    Also called Bobei

    IV

Study groups in NCT04303988
Study groupRoleWhat they receive
Cohort HR-/HER2-ExperimentalHormone receptor negative, HER2 negative participants will receive SHR1316 in combination with bevacizumab plus cisplatin or carboplatin until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Receives: Drug: SHR-1316; Drug: Bevacizumab; Drug: Cisplatin/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate in the CNS

    CNS ORR will be assessed by the investigator according to RANO-BM criteria. According to these criteria Complete Response (CR) will be defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions, no corticosteroids; stable or improved clinically. Partial Response (PR) will be defined as a decrease of at least 30% in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD, sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically.

    Measured: from enrollment to progression or death (for any reason), assessed up to 24 months

Secondary outcomes (5)

  1. Clinical Benefit Rate in the CNS

    CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.

    Measured: from enrollment to progression or death (for any reason), assessed up to 24 months

  2. Progression-free survival

    PFS will be defined as the time from the first dose of treatment to death or disease progression.

    Measured: Up to 2 years

  3. Overall survival

    OS will be defined as the time from the first dose of treatment to death for any cause.

    Measured: Up to 2 years

  4. First progression site

    The first lesion to progress.

    Measured: Up to 2 years

  5. Safety as assessed by percentage of patients with any Adverse Event

    Adverse event according to NCI-CTC AE 5.0

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start30 Mar 2020
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 May 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303988
Sponsor's protocol ID
HR-BLTN 015
Status last verified
Jul 2024
First submitted
24 Feb 2020
Last updated
18 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li T, Zhou T, Wang B, Tao Z, Zhao M, Wang L, Jin J, Zhao Y, Gong C, Cao J, Miao H, Peng W, Wang J, Jin M, Hu X, Zhang J. Phase II Clinical Study of Adebrelimab and Bevacizumab Combined With Cisplatin/Carboplatin in Patients With Triple-Negative Breast Cancer With Brain Metastases (ABC Study). J Clin Oncol. 2026 Sep 10;44(26):2543-2553. doi: 10.1200/JCO-25-02021. Epub 2026 Mar 4.

    PubMed 41779972

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1316, Bevacizumab and Cisplatin/Carboplatin in people with Breast Cancer, run by Fudan University 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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian Zhang, MD (13918273761, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate in the CNS (time frame: from enrollment to progression or death (for any reason), assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04303988, which also lists 1 linked publication.

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 18 Jul 2024.

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