Early-stage Breast CancerPhase 2PREDIXIIHER2NCT03894007
Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer
A Phase 2 study testing Docetaxel, Carboplatin and Trastuzumab in people with Early-stage Breast Cancer and HER2-positive Breast Cancer, run by Renske Altena at 8 sites in Sweden.
Trial summary
This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Docetaxel, Carboplatin and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 8 sitesSweden
- Study dates
- 23 May 2019to 30 Jun 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed PD-L1 expression ≥1% on tumour cells and/or TILs (prescreening phase)
- Able to provide written informed consent
- Female gender
- Patients with breast cancer confirmed by histology, characterised by immunohistochemistry for ER, PR, HER2 and proliferation marker.
- HER2 amplification, IHC 3+ and preferably confirmed by ISH
- Tumor and blood samples available.
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- Age 18 years or older. Elderly patients in adequate condition for the planned therapy, which may be supported by a geriatric assessment (according to ASCO guideline; Mohile et al, JCO 2018)
- Primary breast cancer >20 mm in diameter or verified lymph node metastases
- Adequate bone marrow, renal and hepatic functions (see Table 1)
- LVEF ≥50%
- ECOG performance status 0-1
Who cannot join
- Distant metastases without chance to cure, including node metastases in the contralateral thoracic region or in the mediastinum. An exception is presence of at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available at the participating centre.
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
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- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.
- Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) are permitted provided that they meet the following conditions:
- Rash must cover less than 10% of body surface area (BSA)
- Disease is well controlled at baseline and only requiring low potency topical steroids
- No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids).
- Vaccination with a live vaccine within 30 days of the first dose of study treatment
- A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
- Patients with a history of allergic reaction to IV contrast requiring steroid pre- treatment should have baseline and subsequent tumor assessments performed using MRI.
- The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- Hypersensitivity to atezolizumab
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Sahlgrenska universitetssjukhuset
Gothenburg
Skånes universitetssjukhus
Malmö
Örebro universitetssjukhus
Örebro
Karolinska universitetssjukhuset
Stockholm, SE-17176
S:t Görans sjukhus
Stockholm
Södersjukhuset
Stockholm
Länssjukhuset Sundsvall
Sundsvall
Norrlands universitetssjukhus
Umeå
About this study
Official title: Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.
Read the detailed description
The primary aim is to investigate whether the rate of pCR, after optimal neoadjuvant anti-HER2 based systemic therapy, can be increased by addition of atezolizumab.
Secondary aims are to assess safety and tolerability of this treatment combination, and to identify therapy predictive factors for the anti-HER2 monoclonal antibodies trastuzumab and pertuzumab plus-minus atezolizumab with a backbone of chemotherapy, using modern molecular biological investigational procedures with analyses by repeated biopsies from an intra-patient longitudinal study design.
- Being tested
- Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Epirubicin
- Keywords
- Neoadjuvant therapy, PD-L1 positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 4 courses preoperatively.
CarboplatinDrug
AUC 6 iv, day 1 every third week, 4 courses preoperatively.
TrastuzumabDrug
Also called Herceptin
600 mg sc, day 1 every third week, 4 courses preoperatively. 14 courses postoperatively if complete response.
PertuzumabDrug
Also called Perjeta
840 mg iv starting dose, thereafter 420 mg, day 1 every third week. 14 courses postoperatively if complete response in patients with baseline high risk tumours.
EpirubicinDrug
90 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 3 courses preoperatively
CyclophosphamideDrug
600 mg/m2 iv, day 1 every third week, 3 courses preoperatively
AtezolizumabDrug
Also called Tecentriq
840 mg iv, day 1 every third week, 3 courses preoperatively if randomised to arm A.
Trastuzumab emtansineDrug
Also called Kadcyla
3.6 mg/kg iv, day 1 every third week, 14 courses postoperatively if not complete response.
PaclitaxelDrug
80 mg/m2 iv, day 1 weekly, 12 weeks (4 cycles), in case of (anticipated) unmanageable toxicity related to docetaxel.
| Study group | Role | What they receive |
|---|---|---|
| A: Experimental | Experimental | Four courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide + atezolizumab. In total seven courses of preoperative treatment. Response evaluations after course four.
Postoperatively, if pathologic complete response, patients receive 14 courses of adjuvant trastuzumab every third week. If no pCR patients receive 14 courses of T-DM1 every third week. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Atezolizumab; Drug: Trastuzumab emtansine; Drug: Paclitaxel |
| B: Standard | Active comparator | Four courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide. In total seven courses of preoperative treatment. Response evaluations after course four.
Postoperatively, if pathologic complete response patients receive 14 courses of adjuvant trastuzumab (combined with pertuzumab in case of high-risk disease features) every third week. If no pCR patients receive 14 courses of T-DM1 every third week. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Trastuzumab emtansine; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathological objective response to primary medical treatment
Efficacy measure at surgery that is performed 2-3 weeks after 7 cycles (each cycle lasts 21 days) of preoperative treatment.
Measured: At surgery 2-3 weeks after the last (of 7) cycles of neo-adjuvant systemic therapy.
Secondary outcomes (14)
Objective response rate
Proportion of patients with reduction in tumour burden ≥30% according to RECIST
Measured: After the 4th and 7th cycle (each cycle is 21 days)
Distant disease-free survival
Time from randomisation to distant metastases or death due to breast cancer
Measured: During the study period up to 10 years
Event-free survival
Time from randomisation to breast cancer relapse, contralateral breast cancer, other malignant neoplasms, or death from any cause
Measured: During the study period up to 10 years
Overall survival
Time from randomisation to death from any cause
Measured: During the study period up to 10 years
Rate of breast conserving surgery
Rate
Measured: At surgery
Incidence of treatment-emergent adverse events (Safety)
Rate of grade 3-4 toxicity, rate of % of discontinuation of study medication due to toxicity, rate of AE's of special interest
Measured: During the 18-week period of treatment and until 30 days after termination and during the follow-up period up to ten years
Differences in PROMs according to EORTC C30
Health related Quality of Life using the EORTC C30 scale (EORTC Quality of Life questionnaire C30)
Measured: At baseline, after cycle 4 (a cycle is 21 days), after cycle 7 (a cycle is 21 days), 2 months, 1 year and 5 years after surgery
Differences in PROMs according to EORTC BR23
Health related Quality of Life using the EORTC BR23 scale (EORTC Quality of Life breast specific questionnaire BR23)
Measured: At baseline, after cycle 4 (a cycle is 21 days), after cycle 7 (a cycle is 21 days), 2 months, 1 year and 5 years after surgery
Differences in objective cognitive function
Assessed by an online neuropsychological test (Amsterdam Cognition Scan, validated for use in breast cancer patients [Feenstra et al, J Clin Exp Neuropsychol. 2018 Apr;40(3):253-273. ])
Measured: At baseline, 3 months after surgery, one and five year after treatment start
Treatment prediction, PD-L1
% of Programmed Death Ligand 1 expressing cells [tumour cells and tumour infiltrating lymphocytes]
Measured: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, TMB
Tumour-mutational burden (total number of nonsynonymous mutations per coding area of a tumor genome)
Measured: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, TILs
Percentage of tumour infiltrating lymphocytes
Measured: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, composition of faeces microbiome
Composition of bacterial strains in gastro-intestinal flora (% of different strains measured with DNA/RNA analysis and in microbiotic culture)
Measured: At baseline, after 7th cycle (each cycle is 21 days) before surgery, and one year after surgery
Differences in PROMs
Symptoms using the Memorial Symptoms Assessment Scale (MSAS). The 32-item MSAS scale includes occurrence, frequency, severity, and distress associated with each symptom using four- and five-point rating scales. Symptom burden is calculated as the average of frequency, severity and distress of each symptom. Higher scores indicates higher symptom burden.
Measured: At baseline, after cycle 4 (each cycle is 21 days), after cycle 7 (each cycle is 21 days), 2 months, 1 year and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start23 May 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Security and effect data from another ongoing study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both arms start with four cycles of docetaxel/paklitaxel+carboplatin+trastuzumab+pertuzumab. Thereafter arm A receives three cycles of epirubicin+cyclophosphamide+atezolizumab and arm B receives epirubicin+cyclophosphamide.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renske Altena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renske Altena, Karolinska University Hospital
- Investigators
- Renske Altena, MD, PhD, Principal investigator, Karolinska University HospitalJonas Bergh, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894007
- Sponsor's protocol ID
- PREDIX II HER2
- Other IDs
- 2018-004457-24, 2018
- Acronym
- PREDIXIIHER2
- Status last verified
- Sep 2021
- First submitted
- 21 Mar 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
- ClinicalTrials.gov ID
- NCT03894007
- Acronym / sponsor ID
- PREDIXIIHER2 / PREDIX II HER2
- Keywords
- Neoadjuvant therapy, PD-L1 positive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Security and effect data from another ongoing study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Renske AltenaUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Mar 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.
This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.
Detailed description
The primary aim is to investigate whether the rate of pCR, after optimal neoadjuvant anti-HER2 based systemic therapy, can be increased by addition of atezolizumab.
Secondary aims are to assess safety and tolerability of this treatment combination, and to identify therapy predictive factors for the anti-HER2 monoclonal antibodies trastuzumab and pertuzumab plus-minus atezolizumab with a backbone of chemotherapy, using modern molecular biological investigational procedures with analyses by repeated biopsies from an intra-patient longitudinal study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both arms start with four cycles of docetaxel/paklitaxel+carboplatin+trastuzumab+pertuzumab. Thereafter arm A receives three cycles of epirubicin+cyclophosphamide+atezolizumab and arm B receives epirubicin+cyclophosphamide.
| Arm | Type | Receives |
|---|---|---|
| A: Experimental | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Atezolizumab, Drug: Trastuzumab emtansine, Drug: PaclitaxelFour courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide + atezolizumab. In total seven courses of preoperative treatment. Response evaluations after course four. Postoperatively, if pathologic complete response, patients receive 14 courses of adjuvant trastuzumab every third week. If no pCR patients receive 14 courses of T-DM1 every third week. |
| B: Standard | Active comparator | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Trastuzumab emtansine, Drug: PaclitaxelFour courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide. In total seven courses of preoperative treatment. Response evaluations after course four. Postoperatively, if pathologic complete response patients receive 14 courses of adjuvant trastuzumab (combined with pertuzumab in case of high-risk disease features) every third week. If no pCR patients receive 14 courses of T-DM1 every third week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed PD-L1 expression ≥1% on tumour cells and/or TILs (prescreening phase)
- Able to provide written informed consent
- Female gender
- Patients with breast cancer confirmed by histology, characterised by immunohistochemistry for ER, PR, HER2 and proliferation marker.
- HER2 amplification, IHC 3+ and preferably confirmed by ISH
Key exclusion criteria (18 listed)
- Distant metastases without chance to cure, including node metastases in the contralateral thoracic region or in the mediastinum. An exception is presence of at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available at the participating centre.
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders.
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 |
|---|---|---|
| Docetaxel75 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 4 courses preoperatively. | Drug | A: Experimental, B: Standard |
| CarboplatinAUC 6 iv, day 1 every third week, 4 courses preoperatively. | Drug | A: Experimental, B: Standard |
| TrastuzumabAlso: Herceptin600 mg sc, day 1 every third week, 4 courses preoperatively. 14 courses postoperatively if complete response. | Drug | A: Experimental, B: Standard |
| PertuzumabAlso: Perjeta840 mg iv starting dose, thereafter 420 mg, day 1 every third week. 14 courses postoperatively if complete response in patients with baseline high risk tumours. | Drug | A: Experimental, B: Standard |
| Epirubicin90 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 3 courses preoperatively | Drug | A: Experimental, B: Standard |
| Cyclophosphamide600 mg/m2 iv, day 1 every third week, 3 courses preoperatively | Drug | A: Experimental, B: Standard |
| AtezolizumabAlso: Tecentriq840 mg iv, day 1 every third week, 3 courses preoperatively if randomised to arm A. | Drug | A: Experimental |
| Trastuzumab emtansineAlso: Kadcyla3.6 mg/kg iv, day 1 every third week, 14 courses postoperatively if not complete response. | Drug | A: Experimental, B: Standard |
| Paclitaxel80 mg/m2 iv, day 1 weekly, 12 weeks (4 cycles), in case of (anticipated) unmanageable toxicity related to docetaxel. | Drug | A: Experimental, B: Standard |
Primary outcome
Rate of pathological objective response to primary medical treatment
Time frame: At surgery 2-3 weeks after the last (of 7) cycles of neo-adjuvant systemic therapy.
Efficacy measure at surgery that is performed 2-3 weeks after 7 cycles (each cycle lasts 21 days) of preoperative treatment.
14 secondary outcomes
Objective response rate
Time frame: After the 4th and 7th cycle (each cycle is 21 days)
Distant disease-free survival
Time frame: During the study period up to 10 years
Event-free survival
Time frame: During the study period up to 10 years
Overall survival
Time frame: During the study period up to 10 years
Rate of breast conserving surgery
Time frame: At surgery
Incidence of treatment-emergent adverse events (Safety)
Time frame: During the 18-week period of treatment and until 30 days after termination and during the follow-up period up to ten years
Differences in PROMs according to EORTC C30
Time frame: At baseline, after cycle 4 (a cycle is 21 days), after cycle 7 (a cycle is 21 days), 2 months, 1 year and 5 years after surgery
Differences in PROMs according to EORTC BR23
Time frame: At baseline, after cycle 4 (a cycle is 21 days), after cycle 7 (a cycle is 21 days), 2 months, 1 year and 5 years after surgery
Differences in objective cognitive function
Time frame: At baseline, 3 months after surgery, one and five year after treatment start
Treatment prediction, PD-L1
Time frame: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, TMB
Time frame: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, TILs
Time frame: At baseline, after the 4th cycle (each cycle is 21 days), at surgery and annually during the post-surgical follow-up period up to five years
Treatment prediction, composition of faeces microbiome
Time frame: At baseline, after 7th cycle (each cycle is 21 days) before surgery, and one year after surgery
Differences in PROMs
Time frame: At baseline, after cycle 4 (each cycle is 21 days), after cycle 7 (each cycle is 21 days), 2 months, 1 year and 5 years after surgery
Results and safety
The study was stopped early (reason given: Security and effect data from another ongoing study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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.
Renske Altena, MD, PhD principal investigator
Karolinska University Hospital
Jonas Bergh, MD, PhD study director
Karolinska Institutet
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Carboplatin and Trastuzumab in people with Early-stage Breast Cancer and HER2-positive Breast Cancer, run by Renske Altena at 8 sites in Sweden.
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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. 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?
The study was stopped early (reason given: Security and effect data from another ongoing study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological objective response to primary medical treatment (time frame: At surgery 2-3 weeks after the last (of 7) cycles of neo-adjuvant systemic therapy.). 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 23 Sep 2021.