Breast CancerPhase 2NCT02546232
Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting
A Phase 2 study testing Carboplatin and Paclitaxel in people with Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to investigate the molecular biology of the tumor in relation to treatment response to chemotherapy, in particular paclitaxel compared to the combination paclitaxel and carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2015to 31 Dec 2028
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-specific procedure
- Female or male age ≥ 18 years
- Able to comply with the protocol
- Histologically or cytologically confirmed, HER2 (human epidermal growth factor 2) -negative, men or women with breast adenocarcinoma
- WHO performance status ≤ 2
- Adequate hematological function Absolute neutrophil count (ANC) ≥1.0 x 109/L AND Platelet count ≥100 x 109/L AND Hemoglobin ≥ 10 g/dL (may be transfused to maintain or exceed this level)
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- Adequate liver function Total bilirubin <1.5 x upper limit of normal (ULN) AND AST (aspartate aminotransferase), ALT (alanine aminotransferase) <2.5 x ULN (in cohort I); AST, ALT <5 x ULN (in cohort II)
- Adequate renal function Serum creatinine ≤1.25 x ULN (and if measured: Creatinine clearance within normal reference values)
- Women should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months and premenopausal levels of FSH (follicle stimulating hormone), LH (luteinizing hormone) and oestradiol) must have a negative serum pregnancy test within 28 days prior to inclusion into the study.
Who cannot join
- Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
- Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma, in situ cervix cancer or breast cancer
- Clinically significant (i.e. active) cardiovascular disease for example cardiovascular accident (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA (New York Heart Association) Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
- Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting: A Phase 2 Clinical Trial Protocol Studying Biological Rationale for the Optimal Selection of Treatment Regimens
The purpose of the study is to investigate the molecular biology of the tumor in relation to treatment response to chemotherapy, in particular paclitaxel compared to the combination paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:
Cohort I: Patients with large primary breast cancer (> 2.0 cm) including locally advanced disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to receive carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.
Cohort II: Patients with metastatic disease, available for biopsies before and during therapy are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to receive paclitaxel alone or paclitaxel in combination with carboplatin.
Read the detailed description
High-throughput methods in molecular biology have revealed considerable alterations in the breast cancer genome, transcriptome and proteome with extensive heterogeneity between tumors, potentially explaining the large variation in response to treatment. Classification of breast cancer can be based on such molecular alterations, and have shown to be of clinical relevance. Studies on how genome-wide mRNA (messenger ribonucleic acid) /miRNA (microRNA) expression, copy number alterations (CNAs) and DNA methylation, in addition to the detection of circulating tumor DNA could be used to improve prognostication and aid in therapy decision are highly needed. This project includes a phase II clinical trial where patients will be randomized to treatment with standard anthracycline- and taxane containing chemotherapy with or without the addition of carboplatin. The study aims to include patients in two cohorts as described, with large primary breast cancer (cohort I - 150 patients) and patients with metastatic disease (cohort II - 60 patients). Essential for the study is the mandatory tissue samples for comprehensive molecular analyses to identify markers of response.
- Conditions
- Breast Cancer
- Being tested
- Carboplatin, Paclitaxel
- Keywords
- locally advanced breast cancer, metastatic 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.
CarboplatinDrug
Chemotherapy
PaclitaxelDrug
Also called Taxol
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Paclitaxel 80 mg/m2 weekly for 12 weeks, thereafter current standard chemotherapy for 12 weeks Receives: Drug: Paclitaxel |
| Additional therapy | Experimental | Carboplatin AUC 6 (area under curve; mg/ml/min) once every 3 weeks, for 12 weeks.
Paclitaxel 80 mg/m2 weekly for 12 weeks, thereafter current standard chemotherapy for 12 weeks Receives: Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response: Cohort I - pCR (pathologic complete response), Cohort II - CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease)
The primary objective of the study is to determine the molecular (DNA, RNA, protein and metabolic) changes in the tumors with reference to the obtained therapeutic response in the different treatment arms.
Measured: 24 weeks
Secondary outcomes (2)
Circulating tumor-DNA in plasma
Treatment induced changes and characteristics of circulating tumor DNA compared to tumor response
Measured: 24 weeks
Fatigue (patient reported by standardized questionnaire)
Course of fatigue and predictors of chronic fatigue in the treatment arms.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2021
- Study completion31 Dec 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 Oslo University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Engebraaten, Oslo University Hospital
- Investigators
- Olav Engebraaten, MD, PhD, Principal investigator, Department of Oncology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546232
- Sponsor's protocol ID
- I-BCT-1
- Status last verified
- May 2025
- First submitted
- 11 Aug 2015
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting: A Phase 2 Clinical Trial Protocol Studying Biological Rationale for the Optimal Selection of Treatment Regimens
- ClinicalTrials.gov ID
- NCT02546232
- Acronym / sponsor ID
- I-BCT-1
- Conditions
- Breast Cancer
- Keywords
- locally advanced breast cancer, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- 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 the study is to investigate the molecular biology of the tumor in relation to treatment response to chemotherapy, in particular paclitaxel compared to the combination paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:
Cohort I: Patients with large primary breast cancer (> 2.0 cm) including locally advanced disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to receive carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.
Cohort II: Patients with metastatic disease, available for biopsies before and during therapy are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to receive paclitaxel alone or paclitaxel in combination with carboplatin.
Detailed description
High-throughput methods in molecular biology have revealed considerable alterations in the breast cancer genome, transcriptome and proteome with extensive heterogeneity between tumors, potentially explaining the large variation in response to treatment. Classification of breast cancer can be based on such molecular alterations, and have shown to be of clinical relevance. Studies on how genome-wide mRNA (messenger ribonucleic acid) /miRNA (microRNA) expression, copy number alterations (CNAs) and DNA methylation, in addition to the detection of circulating tumor DNA could be used to improve prognostication and aid in therapy decision are highly needed. This project includes a phase II clinical trial where patients will be randomized to treatment with standard anthracycline- and taxane containing chemotherapy with or without the addition of carboplatin. The study aims to include patients in two cohorts as described, with large primary breast cancer (cohort I - 150 patients) and patients with metastatic disease (cohort II - 60 patients). Essential for the study is the mandatory tissue samples for comprehensive molecular analyses to identify markers of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: PaclitaxelPaclitaxel 80 mg/m2 weekly for 12 weeks, thereafter current standard chemotherapy for 12 weeks |
| Additional therapy | Experimental | Drug: Carboplatin, Drug: PaclitaxelCarboplatin AUC 6 (area under curve; mg/ml/min) once every 3 weeks, for 12 weeks. Paclitaxel 80 mg/m2 weekly for 12 weeks, thereafter current standard chemotherapy for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained prior to any study-specific procedure
- Female or male age ≥ 18 years
- Able to comply with the protocol
- Histologically or cytologically confirmed, HER2 (human epidermal growth factor 2) -negative, men or women with breast adenocarcinoma
- WHO performance status ≤ 2
Key exclusion criteria (5 listed)
- Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
- Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma, in situ cervix cancer or breast cancer
- Clinically significant (i.e. active) cardiovascular disease for example cardiovascular accident (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA (New York Heart Association) Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
- Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
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 |
|---|---|---|
| CarboplatinChemotherapy | Drug | Additional therapy |
| PaclitaxelAlso: TaxolChemotherapy | Drug | Additional therapy, Control |
Primary outcome
Treatment response: Cohort I - pCR (pathologic complete response), Cohort II - CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease)
Time frame: 24 weeks
The primary objective of the study is to determine the molecular (DNA, RNA, protein and metabolic) changes in the tumors with reference to the obtained therapeutic response in the different treatment arms.
2 secondary outcomes
Circulating tumor-DNA in plasma
Time frame: 24 weeks
Fatigue (patient reported by standardized questionnaire)
Time frame: 24 weeks
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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Olav Engebraaten, MD, PhD principal investigator
Department of Oncology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin and Paclitaxel in people with Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. 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 Norway. 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?
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?
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?
Treatment response: Cohort I - pCR (pathologic complete response), Cohort II - CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease) (time frame: 24 weeks). 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 4 Jun 2025.