Breast CancerPhase 3NCT05159193

Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

A Phase 3 study testing pegylated liposomal doxorubicin (PLD), cyclophosphamide (C) and trastuzumab (H) in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a… 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 (PLD), cyclophosphamide (C) and trastuzumab (H)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 372 participants
Where: 1 siteChina
Study dates: 20 Dec 2021to 31 Jan 2028
Phase: Phase 3
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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients aged from 18 to 70 years old;
Histologically confirmed as invasive breast cancer and without previous treatment.;
HER-2 Positive (defined by IHC 3+ or ISH positive);
Tumor > 2cm;
Biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis within 28 days prior to randomization;
Participants must have at least one measurable disease according to RECIST 1.1.

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Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive.
Operable breast cancer with cT2-cT4/cN1-cN3/cM0, according to the AJCC tumor staging manual (8th Edition).
The HR(ER and PR) status of the primary tumor and the expression level of Ki-67 are clear.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
LVEF ≥ 55%;
Brain natriuretic peptide (BNP) (or N-terminal pro brain natriuretic peptide (NT proBNP)) and cardiac troponin assays were within normal values.
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and serum total bilirubin are all ≤2 ULN. Serum creatinine ≤ 1.5 ULN.
Bone marrow function: white blood cell counts ≥ 3.0x10^9/L, absolute neutrophil counts (ANC) ≥ 1.5x10^9/L, platelets ≥ 100x10^9/L, hemoglobin ≥ 90g/L;
Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.

Who cannot join

Breast cancer with distant metastasis;
Participants with multiple lesions (in different quadrants) or bilateral breast cancer;
Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer;
In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1)High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); 2)Angina pectoris requiring anti-angina medication; 3)Clinically significant valvular heart disease; 4)ECG showing transmural myocardial infarction; 5)Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6)Myocardial infarction; 7)Congestive heart failure;
Participants have the following serious illnesses or medical conditions, including but not limited: 1)History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2)Active uncontrolled infection; 3)Active peptic ulcer, unstable diabetes;
A history of other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin;

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Treatment with any investigational drug within 28 days prior to randomization;
Participants who are known to be allergic to the active or other components of the study treatment or have contraindications for surgery;
Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
Participants who were judged by the investigator to be unsuitable for this study.

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

Sunyat-sen Memorial Hospital
Guandong, Guangdong
Qiang Liu, PhD, 86-020-34071157, victorlq@hotmail.com
Qiang Liu, PhD
Recruiting

Other trials in China

About this study

Official title: A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

This is a multicenter, open label, non-inferiority, randomized controlled clinical study.

The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.

Conditions: Breast Cancer
Being tested: pegylated liposomal doxorubicin (PLD), cyclophosphamide (C), trastuzumab (H), pertuzumab (P), docetaxel (T)
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 doxorubicin (PLD)Drug
Also called duomeisu, Doxorubicin Hydrochloride Liposome Injection
pegylated liposomal doxorubicin (PLD) 30 mg/m^2, i.v., d1, q3w
cyclophosphamide (C)Drug
Also called huanlinxianan
cyclophosphamide (C) 600 mg/m^2, i.v., d1, q3w
trastuzumab (H)Drug
Also called qutuozhudankang
trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
pertuzumab (P)Drug
Also called patuozhudankang
pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w
docetaxel (T)Drug
Also called duoxitasai
docetaxel (T) 90~100 mg/m^2, i.v., d1, q3w
docetaxel (T)Drug
Also called duoxitasai
docetaxel (T) 75 mg/m^2, i.v., d1, q3w
carboplatin (Cb)Drug
Also called kabo
carboplatin (Cb) AUC 6, i.v., d1, q3w
trastuzumab (H)Drug
Also called qutuozhudankang
trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w
pertuzumab (P)Drug
Also called patuozhudankang
pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w

Study groups in NCT05159193
Study group	Role	What they receive
PLD + C + HP followed by THP	Experimental	pegylated liposomal doxorubicin (PLD) 30 mg/m^2, i.v., d1 + cyclophosphamide (C) 600 mg/m^2, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 followed by docetaxel (T) 90~100 mg/m^2, i.v., d1 + trastuzumab (H) 6 mg/kg, i.v., d1 + pertuzumab (P) 420 mg, i.v., d1 q3w, for 4 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery. Receives: Drug: pegylated liposomal doxorubicin (PLD); Drug: cyclophosphamide (C); Drug: trastuzumab (H); Drug: pertuzumab (P); Drug: docetaxel (T)
TCbHP	Active comparator	docetaxel (T) 75 mg/m^2, i.v., d1 + carboplatin (Cb) AUC 6, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 q3w, for 6 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery. Receives: Drug: docetaxel (T); Drug: carboplatin (Cb); Drug: trastuzumab (H); Drug: pertuzumab (P)

What is being measured

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

Pathological complete response (pCR) rate
The percentage of participants without residual invasive cancer (ypT0/Tis ypN0 in the current AJCC staging system) when the complete resected breast specimen and all sampled regional lymph nodes were evaluated with hematoxylin and eosin staining after completion of systemic neoadjuvant therapy.
Measured: Within 2 to 5 weeks after completion of neoadjuvant therapy

Secondary outcomes (7)

Objective response rate (ORR) at the end of neoadjuvant chemotherapy
The number of participants who achieved complete response and partial response at the end of neoadjuvant chemotherapy as a percentage of the overall evaluable participants.
Measured: After the last dose to before surgery or within 21 days
5-year disease-free survival (DFS) rate
DFS is defined as the time from randomization to tumor recurrence or death from any cause. 5-year DFS rate is the percentage of participants with DFS from enrollment through 5 years.
Measured: 5 years
Breast conservation rate at surgery
Percentage of participants receiving breast-conserving surgery after neoadjuvant therapy.
Measured: Within 2 to 5 weeks after completion of neoadjuvant therapy
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0, including overall and Grade 3/4 adverse events.
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0, including overall and Grade 3/4 adverse events.
Measured: 5 years
Percentage of Participants with dose reductions of chemotherapy due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Percentage of Participants with dose reductions of chemotherapy due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Measured: 1 year
Percentage of Participants with chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Percentage of Participants with chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Measured: 1 year
Relative dose intensity (RDI)
RDI=actual dose intensity* / standard dose intensity# actual dose intensity* = drug standard dose (mg/m^2) / weeks of administration per cycle (week) standard dose intensity# = actual standard dose (mg/m^2) / actual dosing weeks (week)
Measured: 1 year

Timeline

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

20 Dec 202131 Jan 2028

First posted16 Dec 2021
Study start20 Dec 2021
Primary completion30 Oct 2024 (estimated)
Study completion31 Jan 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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 372 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05159193
Sponsor's protocol ID: CSPC-DMS-BC-K07
Status last verified: Jan 2024
First submitted: 25 Nov 2021
Last updated: 2 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer
ClinicalTrials.gov ID: NCT05159193
Acronym / sponsor ID: CSPC-DMS-BC-K07
Conditions: Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 372 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Study start: 20 Dec 2021 (actual)
Primary completion: 30 Oct 2024 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 16 Dec 2021 (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.

This is a multicenter, open label, non-inferiority, randomized controlled clinical study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PLD + C + HP followed by THP	Experimental	Drug: pegylated liposomal doxorubicin (PLD), Drug: cyclophosphamide (C), Drug: trastuzumab (H), Drug: pertuzumab (P), Drug: docetaxel (T)pegylated liposomal doxorubicin (PLD) 30 mg/m^2, i.v., d1 + cyclophosphamide (C) 600 mg/m^2, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 followed by docetaxel (T) 90~100 mg/m^2, i.v., d1 + trastuzumab (H) 6 mg/kg, i.v., d1 + pertuzumab (P) 420 mg, i.v., d1 q3w, for 4 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery.
TCbHP	Active comparator	Drug: docetaxel (T), Drug: carboplatin (Cb), Drug: trastuzumab (H), Drug: pertuzumab (P)docetaxel (T) 75 mg/m^2, i.v., d1 + carboplatin (Cb) AUC 6, i.v., d1 + trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1 + pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1 q3w, for 6 cycles. After neoadjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab (6mg/kg) combined with pertuzumab (420mg), i.v., d1, q3w, regardless of surgery.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Female patients aged from 18 to 70 years old;
Histologically confirmed as invasive breast cancer and without previous treatment.;
HER-2 Positive (defined by IHC 3+ or ISH positive);
Tumor > 2cm;
Biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis within 28 days prior to randomization;

Key exclusion criteria (10 listed)

Breast cancer with distant metastasis;
Participants with multiple lesions (in different quadrants) or bilateral breast cancer;
Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer;
In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1)High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); 2)Angina pectoris requiring anti-angina medication; 3)Clinically significant valvular heart disease; 4)ECG showing transmural myocardial infarction; 5)Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6)Myocardial infarction; 7)Congestive heart failure;
Participants have the following serious illnesses or medical conditions, including but not limited: 1)History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2)Active uncontrolled infection; 3)Active peptic ulcer, unstable diabetes;

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 doxorubicin (PLD)Also: duomeisu, Doxorubicin Hydrochloride Liposome Injectionpegylated liposomal doxorubicin (PLD) 30 mg/m^2, i.v., d1, q3w	Drug	PLD + C + HP followed by THP
cyclophosphamide (C)Also: huanlinxianancyclophosphamide (C) 600 mg/m^2, i.v., d1, q3w	Drug	PLD + C + HP followed by THP
trastuzumab (H)Also: qutuozhudankangtrastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w	Drug	PLD + C + HP followed by THP
pertuzumab (P)Also: patuozhudankangpertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w	Drug	PLD + C + HP followed by THP
docetaxel (T)Also: duoxitasaidocetaxel (T) 90~100 mg/m^2, i.v., d1, q3w	Drug	PLD + C + HP followed by THP
docetaxel (T)Also: duoxitasaidocetaxel (T) 75 mg/m^2, i.v., d1, q3w	Drug	TCbHP
carboplatin (Cb)Also: kabocarboplatin (Cb) AUC 6, i.v., d1, q3w	Drug	TCbHP
trastuzumab (H)Also: qutuozhudankangtrastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w	Drug	TCbHP
pertuzumab (P)Also: patuozhudankangpertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w	Drug	TCbHP

Primary outcome

Pathological complete response (pCR) rate
Time frame: Within 2 to 5 weeks after completion of neoadjuvant therapy
The percentage of participants without residual invasive cancer (ypT0/Tis ypN0 in the current AJCC staging system) when the complete resected breast specimen and all sampled regional lymph nodes were evaluated with hematoxylin and eosin staining after completion of systemic neoadjuvant therapy.

7 secondary outcomes

Objective response rate (ORR) at the end of neoadjuvant chemotherapy
Time frame: After the last dose to before surgery or within 21 days
5-year disease-free survival (DFS) rate
Time frame: 5 years
Breast conservation rate at surgery
Time frame: Within 2 to 5 weeks after completion of neoadjuvant therapy
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0, including overall and Grade 3/4 adverse events.
Time frame: 5 years
Percentage of Participants with dose reductions of chemotherapy due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Time frame: 1 year
Percentage of Participants with chemotherapy delay due to Grade 3/4 adverse events as assessed by NCI-CTCAE V5.0
Time frame: 1 year
Relative dose intensity (RDI)
Time frame: 1 year

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 2 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Sunyat-sen Memorial Hospital

Guandong, China

86-020-34071157

victorlq@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 10 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 2 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: Within 2 to 5 weeks after completion of neoadjuvant therapy). 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 NCT05159193.

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 2 Feb 2024.