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Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting

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ClinicalTrials.gov Identifier: NCT02546232
Recruitment Status : Recruiting
First Posted : September 10, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Olav Engebraaten, Oslo University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Carboplatin Drug: Paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Control
Paclitaxel 80 mg/m2 weekly for 12 weeks, thereafter current standard chemotherapy for 12 weeks
Drug: Paclitaxel
Chemotherapy
Other Name: Taxol

Experimental: Additional therapy

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

Drug: Carboplatin
Chemotherapy

Drug: Paclitaxel
Chemotherapy
Other Name: Taxol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Circulating tumor-DNA in plasma [ Time Frame: 24 weeks ]
    Treatment induced changes and characteristics of circulating tumor DNA compared to tumor response

  2. Fatigue (patient reported by standardized questionnaire) [ Time Frame: 24 weeks ]
    Course of fatigue and predictors of chronic fatigue in the treatment arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-specific procedure
  2. Female or male age ≥ 18 years
  3. Able to comply with the protocol
  4. Histologically or cytologically confirmed, HER2 (human epidermal growth factor 2) -negative, men or women with breast adenocarcinoma
  5. WHO performance status ≤ 2
  6. 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)
  7. 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)
  8. Adequate renal function Serum creatinine ≤1.25 x ULN (and if measured: Creatinine clearance within normal reference values)
  9. 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.

Exclusion Criteria:

  1. 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).
  2. 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
  3. 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
  4. Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546232


Contacts
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Contact: Olav Engebraaten, MD, PhD +47 23026600 olav.engebraten@ous-hf.no
Contact: Bjørn Naume, MD, PhD +47 22934000 bjorn.naume@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Alexandra Østgaard    +4723026600    UXANUL@oslo-universitetssykehus.no   
Contact: Mette Nordberg Stokke    +4722934000    Mette.Norberg.Stokke@oslo-universitetssykehus.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Olav Engebraaten, MD, PhD Department of Oncology, Oslo University Hospital

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Responsible Party: Olav Engebraaten, Consultant oncologist / Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02546232     History of Changes
Other Study ID Numbers: I-BCT-1
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Olav Engebraaten, Oslo University Hospital:
locally advanced breast cancer
metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action