Breast CancerPhase 1/2NCT03994107
Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
A Phase 1/2 study testing Pegylated Liposomal Doxorubicin, Albumin-bound paclitaxel and Trastuzumab in people with Breast Cancer, run by Peking Union Medical College at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pegylated Liposomal Doxorubicin, Albumin-bound paclitaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Jan 2021
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
- Female patients aged from 18 to 70 years old;
- Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
- Clinical stageⅡ-Ⅲ;
- HER-2 Positive（defined by: IHC 3+ or ISH positive）;
- Without previous treatment for this breast cancer;
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- Patients must have at least one measurable disease according to RECIST 1.1;
- ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
- LVEF≥55%;
- Normal ECG;
- Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
- Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
- Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.
Who cannot join
- New York Heart Association (NYHA) class ≥Ⅱ heart failure.
- Known or suspected hypersusceptibility to any agents used in the treatment protocol.
- Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
- participating in other clinical trials within 4 weeks before this study.
- Serious heart disease, including but not limited to:
- 1) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.
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- 9. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.
- 9）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.
- 10）Other conditions considered to be inappropriate to be enrolled by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fei Ma
Beijing, Beijing Municipality, 100021
Fei Ma, MD, +86-10-87787652, mafei@126.com
About this study
Official title: A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
Read the detailed description
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.
This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
- Conditions
- Breast Cancer
- Being tested
- Pegylated Liposomal Doxorubicin, Albumin-bound paclitaxel, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal DoxorubicinDrug
First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6.
Second phase
PLD：MTD. IV, d1, q21d×6.
Albumin-bound paclitaxelDrug
220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
TrastuzumabDrug
8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
| Study group | Role | What they receive |
|---|---|---|
| PLD/albumin-bound paclitaxel/Trastuzumab | Experimental | First phase
PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.
Second phase
PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6. Receives: Drug: Pegylated Liposomal Doxorubicin; Drug: Albumin-bound paclitaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response(pCR) rate
Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery
Measured: 5 months
Secondary outcomes (3)
Rate of Breast conserving surgery
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy
Measured: 5 months
Rate of surgery
Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy
Measured: 5 months
adverse events
Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Oct 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Fei Ma, Peking Union Medical College
- Investigators
- Fei Ma, MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994107
- Sponsor's protocol ID
- CSPC-DMS-BC-17
- Status last verified
- Jan 2020
- First submitted
- 19 Jun 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03994107
- Acronym / sponsor ID
- CSPC-DMS-BC-17
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 21 Jun 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
Detailed description
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.
This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLD/albumin-bound paclitaxel/Trastuzumab | Experimental | Drug: Pegylated Liposomal Doxorubicin, Drug: Albumin-bound paclitaxel, Drug: TrastuzumabFirst phase PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6. Second phase PLD: maximum tolerated dose (MTD). IV, d1, q21d×6. albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
- Female patients aged from 18 to 70 years old;
- Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
- Clinical stageⅡ-Ⅲ;
- HER-2 Positive（defined by: IHC 3+ or ISH positive）;
Key exclusion criteria (9 listed)
- New York Heart Association (NYHA) class ≥Ⅱ heart failure.
- Known or suspected hypersusceptibility to any agents used in the treatment protocol.
- Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
- participating in other clinical trials within 4 weeks before this study.
- Serious heart disease, including but not limited to:
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 |
|---|---|---|
| Pegylated Liposomal DoxorubicinFirst phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6. Second phase PLD：MTD. IV, d1, q21d×6. | Drug | PLD/albumin-bound paclitaxel/Trastuzumab |
| Albumin-bound paclitaxel220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6. | Drug | PLD/albumin-bound paclitaxel/Trastuzumab |
| Trastuzumab8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6. | Drug | PLD/albumin-bound paclitaxel/Trastuzumab |
Primary outcome
Pathological complete response(pCR) rate
Time frame: 5 months
Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery
3 secondary outcomes
Rate of Breast conserving surgery
Time frame: 5 months
Rate of surgery
Time frame: 5 months
adverse events
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Fei Ma, MD principal investigator
Cancer Hospital Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pegylated Liposomal Doxorubicin, Albumin-bound paclitaxel and Trastuzumab in people with Breast Cancer, run by Peking Union Medical College 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 13 inclusion and 9 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 22 Jan 2020. 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 combined 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.
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 Fei Ma, MD (+8613910217780, 13910217780@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response(pCR) rate (time frame: 5 months). 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 22 Jan 2020.