HER2-positive Breast CancerPhase 3PHARE-CNCT05388500
Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
A Phase 3 study testing Paclitaxel + Trastuzumab and Trastuzumab in people with HER2-positive Breast Cancer, run by Institut de cancérologie Strasbourg Europe.
Trial summary
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (< 3 cm) without axillary lymph node involvement or small (< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Paclitaxel + Trastuzumab and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 15 Dec 2030
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor
- Without suspicious axillary nodes
- Tumor size < 30 mm
- Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer
- Left Ventricular Ejection Fraction (LVEF) obtained and > 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month)
- Overexpression of HER-2 in the invasive component of the primary tumor as indicated by one of the following:
- 3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
- With signed Informed consent
Who cannot join
- Previous anti-HER2 treatment (except for HERCEPTIN)
- Cardiac disease or other medical conditions preventing trastuzumab administration
- Known allergy to trastuzumab, murine proteins or other excipients
- Pregnant or breastfeeding women
- Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons
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: Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (< 3 cm) without axillary lymph node involvement or small (< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size< 3 cm, N0) early breast cancer.
Read the detailed description
PHARE-C is an open-label, randomized, phase III, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer to allow for comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy.
Non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. Treatment tolerance and cardiac toxicity will be assessed as secondary objectives.
In case of non pCR, a rescue by Trastuzumab emtansine (T-DM1) is planned to control the survival outcome.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Paclitaxel + Trastuzumab, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + TrastuzumabDrug
Regarding neoadjuvant treatment :
- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SubCutaneous (SC) (600mg fixed dose) every 3 weeks + weekly Paclitaxel IV : 80 to 90 mg/m2
Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total :
- in case of pCR : patient will receive trastuzumab
- in case of non pCR : patients will receive trastuzumab emtansine (T-DM1)
TrastuzumabDrug
Regarding neoadjuvant treatment :
- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SC (600mg fixed dose) every 3 weeks
Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total :
- in case of pCR : patient will receive trastuzumab
- in case of non pCR : patients will receive trastuzumab emtansine (T-DM1)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Paclitaxel + Trastuzumab) | Active comparator | Not described Receives: Drug: Paclitaxel + Trastuzumab |
| Group B (Trastuzumab) | Experimental | Not described Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Time from the date of randomization to the date of progression
Measured: up to 5 years
Secondary outcomes (6)
Cardiac toxicity
defined by Ventricular Ejection Fraction measure according to the technique used, clinical examination or any other appropriate exams
Measured: up to 5 years
Treatment toxicity
Adverse Event and Serious Adverse Event due to trastuzumab or paclitaxel graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: up to 5 years
Total pathological Complete Response (tpCR)
Defined by complete absence of cancerous cells in breast, axillary lymph node chain and/or axillary sentinel lymph node (ypT0/is) in excised tissues
Measured: through surgery completion, an average of 12 weeks
Breast pathological Complete Response (bpCR)
Defined by complete absence of cancerous cells in breast (ypT0/is, ypN0) in excised tissues
Measured: through surgery completion, an average of 12 weeks
Distant metastasis Free Survival
Time from the date of randomization to the date of 1st metastasis
Measured: up to 5 years
Overall Survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier PIVOT, MD, PhD, Study chair, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388500
- Sponsor's protocol ID
- 2022-008
- Acronym
- PHARE-C
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT05388500
- Acronym / sponsor ID
- PHARE-C / 2022-008
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 24 May 2022 (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.
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (< 3 cm) without axillary lymph node involvement or small (< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size< 3 cm, N0) early breast cancer.
Detailed description
PHARE-C is an open-label, randomized, phase III, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer to allow for comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy.
Non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. Treatment tolerance and cardiac toxicity will be assessed as secondary objectives.
In case of non pCR, a rescue by Trastuzumab emtansine (T-DM1) is planned to control the survival outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Paclitaxel + Trastuzumab) | Active comparator | Drug: Paclitaxel + Trastuzumab |
| Group B (Trastuzumab) | Experimental | Drug: Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor
- Without suspicious axillary nodes
- Tumor size < 30 mm
- Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer
- Left Ventricular Ejection Fraction (LVEF) obtained and > 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month)
Key exclusion criteria (5 listed)
- Previous anti-HER2 treatment (except for HERCEPTIN)
- Cardiac disease or other medical conditions preventing trastuzumab administration
- Known allergy to trastuzumab, murine proteins or other excipients
- Pregnant or breastfeeding women
- Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons
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 |
|---|---|---|
| Paclitaxel + TrastuzumabRegarding neoadjuvant treatment : - 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SubCutaneous (SC) (600mg fixed dose) every 3 weeks + weekly Paclitaxel IV : 80 to 90 mg/m2 Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patients will receive trastuzumab emtansine (T-DM1) | Drug | Group A (Paclitaxel + Trastuzumab) |
| TrastuzumabRegarding neoadjuvant treatment : - 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SC (600mg fixed dose) every 3 weeks Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patients will receive trastuzumab emtansine (T-DM1) | Drug | Group B (Trastuzumab) |
Primary outcome
Time to progression
Time frame: up to 5 years
Time from the date of randomization to the date of progression
6 secondary outcomes
Cardiac toxicity
Time frame: up to 5 years
Treatment toxicity
Time frame: up to 5 years
Total pathological Complete Response (tpCR)
Time frame: through surgery completion, an average of 12 weeks
Breast pathological Complete Response (bpCR)
Time frame: through surgery completion, an average of 12 weeks
Distant metastasis Free Survival
Time frame: up to 5 years
Overall Survival
Time frame: up to 5 years
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 27 May 2022.
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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.
Xavier PIVOT, MD, PhD study chair
Institut de cancérologie Strasbourg Europe
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel + Trastuzumab and Trastuzumab in people with HER2-positive Breast Cancer, run by Institut de cancérologie Strasbourg Europe.
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 5 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: opening soon, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: up to 5 years). 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 27 May 2022.