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HER2-positive Breast CancerPHC-BCNCT04281641

Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer

A study testing TCHP in people with HER2-positive Breast Cancer, run by Fudan 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
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Trial summary

This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
TCHP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
21 Apr 2020to 30 Apr 2030
Phase
Interventional
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
  • Primary tumor greater than (>) 2 cm in diameter.
  • Age ≥ 18 years and < 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1.
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55%
  • Availability of tumor tissue specimen after surgery.
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  • Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
  • Histologically proven diagnosis of breast cancer.
  • Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
  • Had hormonal receptors (ER and PgR) assessed.
  • Signed informed consent.
  • Able to comply with the protocol.

Who cannot join

  • Metastatic disease (Stage IV) or bilateral breast cancer.
  • Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
  • Prior breast or non-breast malignancy within 5 years prior to study entry.
  • Inadequate bone marrow, renal, or liver function
  • History or evidence of cardiovascular condition
  • Severe, uncontrolled systemic disease
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  • Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
  • Pregnancy or breast-feeding women.
  • Participants who received any investigational treatment within 4 weeks of study start.
  • Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
  • Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids]).
  • Known hypersensitivity to any of the study drugs or excipients

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiong Wu, MD contact

+862164175590 ext. 88607

wujiong1122@vip.sina.com

China1 site, 1 recruiting

  • Shanghai Cancer Center, Fudan University

    Shanghai, Shanghai Municipality, 200000

    Jiong Wu, MD, +862164175590 ext. 88607, wujiong1122@vip.sina.com

    Recruiting

Other trials in China

About this study

Official title: Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer

This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.

Read the detailed description

This study is to evaluate the correlation between early changes in multiple markers and pathological complete response in breast and lyphm nodes (tpCR) in patients with HER2-positive breast cancer receiving carboplatin, docetaxel and trastuzumab plus pertuzumab (TCHP) pre-operatively. The markers would be examined by gene expression assays, fluorodeoxyglucose positron emission tomography (18F-FDG-PET), 68 Ga-Affibody HER-2 Imaging PET, and organoid drug sensitivity test. Approximately 94 patients were treated with PH-based neoadjuvant therapy followed by surgery, and would complete 1 year of PH-based regimen in the adjuvant setting. The primary endpoint is the percent change of SUVmax from baseline to Day 15 (after the first cycle of anti HER-2 targeting drug treatment) on FDG PET and HER-2 imagining PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab and trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review.

Being tested
TCHP

What participants receive

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

  • TCHPDiagnostic test

    Drug: Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV Other Name: Herceptin

    Drug: Pertuzumab 840 mg as a loading dose, then 420 mg every 3 weeks, IV Other Name: Perjeta

    Drug: carboplatin at target area under the plasma concentration-time curve (AUC) 6

    Drug: docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w).

    All study drugs were administered intravenously.

    Procedure: 18-FDG-PET and 68 Ga-Affibody HER-2 Imaging PET will be performed at baseline, on day 15 and before surgery

    Genomic alterations (mutations/somatic rearrangements) are detected at baseline, on day 15 and before surgery.

Study groups in NCT04281641
Study groupRoleWhat they receive
TCHPExperimentalNeoadjuvant Therapy (Cycles 1-7): Cycle 1: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) Cycle 2-7: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) + followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w). Adjuvant Therapy:patients would complete 1 year of PH-based regimen in the adjuvant setting. Patients are assessed by [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and 68Ga-Affibody HER-2 Imaging PET. Besides, the changes of biomarkers would be examined by gene sequencing and organoid drug sensitivity test.
Receives: Diagnostic Test: TCHP

What is being measured

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

  1. Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response

    Change in SUVmax from baseline to Day 15 on 18-FDG PET and 68Ga-Affibody HER-2 Imaging PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab.

    Measured: From baseline to day 15

Secondary outcomes (4)

  1. Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)

    To determine whether the composite markers can predict pathologic complete response in the breast and lymph nodes in HER-2 positive breast cancer with PH combination with chemotherapy adjuvant therapy. Defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy (ypT0/Tis ypN0).

    Measured: Immediately after the surgery

  2. Invasive disease-free survival (iDFS) (excluding Second Primary Non-Breast Cancer [SPNBC])

    To determine the correlation between the composite markers and invasive disease free survival in HER-2 positive breast cancer patients receiving docetaxel, carboplatin, and trastuzumab plus pertuzumab pre-operatively. iDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer recurrence; distant recurrence; death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.

    Measured: Following surgery until Year 5

  3. iDFS (including SPNBC)

    The iDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer recurrence; distant recurrence; death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

    Measured: Following surgery until Year 5

  4. Overall survival (OS)

    To determine the correlation between the composite markers and overall survival in HER-2 positive breast cancer patients receiving docetaxel, carboplatin, and trastuzumab plus pertuzumab pre-operatively. Percentage of participants who died due to any cause is reported.

    Measured: Following surgery until Year 5

Timeline

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

  1. First posted24 Feb 2020
  2. Study start21 Apr 2020
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2030 (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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281641
Sponsor's protocol ID
SCHBCC-NO28
Acronym
PHC-BC
Status last verified
Apr 2020
First submitted
12 Feb 2020
Last updated
4 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Yang B, Chen M, Li P, Xiao X, Xiu B, Bai J, Sun Y, Xu X, Zhang J, Qiao Y, Xue J, Shao Z, Song S, Wu J. A prospective single-center cohort study: integrating PET imaging and genomics to identify early biomarkers of response to dual-targeted PH neoadjuvant therapy in breast cancer. Int J Surg. 2026 Feb 1;112(2):3312-3324. doi: 10.1097/JS9.0000000000003931. Epub 2025 Nov 11.

    PubMed 41231642

Questions about this trial

What is this clinical trial studying?

A study testing TCHP in people with HER2-positive 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 12 inclusion and 12 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 4 May 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.

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 Jiong Wu, MD (+862164175590 ext. 88607, wujiong1122@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response (time frame: From baseline to day 15). 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 NCT04281641, 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 4 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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