Clinical Trials Logo

Clinical Trial Summary

This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment.

Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.


Clinical Trial Description

Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can be first line SACT or any subsequent line.

All patients undergo a baseline CT scan (thorax/abdomen/pelvis) and isotope bone scan prior to commencing their new systemic therapy. All CT and bone scans are performed according to standard departmental protocols, with no deviations required. WB-MRI are performed within 2 weeks of study entry. CT scans and WB-MRI are then performed every 12 weeks until week 96, and then every 24 weeks until the patient completes the study. The reporting radiologist who interprets the CT scans is blinded to the images and results of the WB-MRI scan and vice versa.

At study commencement Participants are required to have had a CT scan of the thorax, abdomen and pelvis and a bone scan (bone scintigraphy with technetium-99m-methylene diphosphonate) no more than 4 weeks prior to trial entry to ensure that they have bony-only metastatic disease, as defined using standard imaging. Baseline WB-MRI scans are performed within 2 weeks of entry into the study.

Participants are assessed in clinic and a baseline physical examination is undertaken. Any additional tests required for the initiation of the new SACT are performed at the discretion of the treating clinician and according to local protocols.

During the study CT scans and WB-MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in the study protocol). Scans are performed within the range of 7 days prior and 7 days after the planned 12 weekly scan interval date.

If there is evidence of equivocal disease progression on WB-MRI only, a repeat WB-MRI is undertaken between 28 and 42 days after the equivocal WB-MRI to confirm or refute the presence of progressive disease. If this confirmed disease progression, then the date of progression is defined as that of the original WB-MRI (i.e. the one performed 4-6 weeks earlier). No repeat CT scans are performed alongside the confirmatory WB-MRI.

Participants are reviewed in outpatient clinic after every imaging time point so that the results of the CT and WB-MRI can be relayed to them by their oncologist and a decision can be made about their ongoing treatment. If more frequent clinic reviews are required then these are not prohibited by the trial protocol. As with the frequency of imaging, the required trial clinic visits change to every 24 weeks after the week 96 visit. During these clinic visits a clinical assessment is made and a full physical examination undertaken. Current anti-cancer drug therapy, including any changes, are documented. Any skeletal related events are also documented. Skeletal related events are defined within the RESPECT study as:

- pathological fracture

- metastatic spinal cord compression

- radiotherapy for bone pain

- surgery to site of bone metastasis Case report forms are completed by the trial administrators at every imaging time point. These are referred to as week 12, week 24, week 36 and so forth.

Patient Imaging Questionnaires are performed at the week 12 and week 36 visits, and are completed by the patients within the radiology department soon after their CT and WB-MRI scans has been performed.

End of study

The end of the study protocol is reached when any of the following occur:

1. Progressive bone and/or visceral disease is demonstrated on CT scan and WB-MRI (as defined in section X).

2. Unequivocal progressive bone and/or visceral disease is demonstrated on WB-MRI alone (as defined in section X).

3. CT and/or WB-MRI findings requiring intervention such as palliative radiotherapy, or a change in systemic therapy.

4. Equivocal evidence of progressive bone and/or visceral disease (not meeting the full criteria for disease progression in section 7.1.3) demonstrated on WB-MRI only, with confirmation of findings on repeat WB-MRI undertaken 4-6 weeks later.

5. Symptomatic skeletal disease or evidence of clinical progression of disease that necessitates a change in systemic therapy.

A repeat nuclear medicine bone scan is undertaken once the participant met one of the end of study criteria above. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03266744
Study type Interventional
Source East and North Hertfordshire NHS Trust
Contact
Status Active, not recruiting
Phase N/A
Start date April 21, 2016
Completion date May 2018

See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2