Breast CancerKEYMOVENCT05976815
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
A study testing Combined Aerobic and Resistance Exercise in people with Breast Cancer, run by University Institute of Maia at 1 site in Portugal.
Trial summary
One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Combined Aerobic and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePortugal
- Study dates
- 31 Jul 2023to 1 Aug 2026
- Phase
- Interventional
- 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
- being female gender;
- age equals or greater than 18 years old;
- having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
- planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
- being followed by the oncology department of the CHVNG/E;
- medical oncologists consents the practice of physical exercise;
- the patient is capable of providing written informed consent;
- the participant accepts to be allocated to the control or experimental group, according to the randomization.
Who cannot join
- previous cancer diagnostic;
- evidence of synchronous oncologic disease;
- physical or psychiatric contraindication to the practice of physical exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alberto Alves, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Vila Nova Gaia e Espinho
Vila Nova de Gaia, Porto District, 4434-502
Nuno Rato, MSc, +351919985852, nuno.rato@umaia.pt
Nuno Rato, MSc
About this study
Official title: Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.
- Conditions
- Breast Cancer
- Being tested
- Combined Aerobic and Resistance Exercise
- Keywords
- Breast Cancer, Neoadjuvant Chemotherapy, Physical Exercise, Pathologic Complete Response, Immune System
- Medical subject headings
- Breast Neoplasms, Motor Activity, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Resistance ExerciseBehavioural
Apart from the neoadjuvant chemotherapy treatment (standard of care), participants allocated to the experimental group will additionally participate in a supervised physical exercise program that comprises 3 weekly sessions during the months that the patient is undergoing chemotherapy treatment. Each 75-minute session will comprise a 10-minute warm up, 30 minutes of strength training involving exercise for the major muscle groups, 30 minutes of aerobic training at 40-89% of heart rate reserve and a 5-minute cool down.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive neoadjuvant chemotherapy alone (standard of care). |
| Experimental Group | Experimental | The experimental group will receive neoadjuvant chemotherapy (standard of care) in conjunction with an exercise intervention. The exercise intervention will be implemented concurrently for the full duration of the neoadjuvant chemotherapy treatment. Receives: Behavioral: Combined Aerobic and Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Pathological response as the primary outcome will be assessed by a blinded pathologist from the tumour surgical specimens after the breast surgery (post-intervention) and will be defined as complete, partial or no response. Besides pathological complete response (defined as ypT0/ypN0), groups will be compared as those with response (complete or partial) versus those with no response. The residual cancer burden which quantifies residual disease after NAC (post-intervention) will also be assessed.
Measured: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.
Secondary outcomes (28)
Treatment Tolerance - clinically assessed.
Number of participants with clinically assessed treatment-related adverse events. Will be assessed according to the Common Terminology Criteria for Adverse Events v5.0. The scale uses a minimal value of 1 and a maximal value of 5 to grade each adverse event, with higher scores representing worse outcomes.
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Treatment Tolerance - patient reported.
Number of participants with patient-reported adverse events. Will be assessed using the Patient reported outcomes version of the Common Terminology Criteria for Adverse Events v1.0 questionnaire. The scale uses a minimal rating 0 and a maximal rating of 4 to grade each adverse event, with higher scores representing worse outcomes.
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Chemotherapy Relative Dose Intensity
Chemotherapy relative dose intensity will be calculated by the following formula: (Delivered dose intensity / Standard dose intensity) x 100%, where Delivered dose intensity = (Delivered total dose, in mg/m2)/(actual time to complete chemotherapy with imputation for missed cycles, in days) and Standard Dose Intensity = (Standard total dose, in mg/m2)/(standard time to complete chemotherapy, in days).
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Dose Reductions
Number of patients that had to reduce the dose of chemotherapy from the dose of chemotherapy initially prescribed (standard dose intensity).
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Delays
Number of patients that had to delay a cycle of chemotherapy, in comparison to what had initially been prescribed (standard dose intensity).
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Early Discontinuations
Number of patients that had to interrupt chemotherapy before the standard dose had been administrated.
Measured: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Percentage of Tumor Infiltrating Lymphocytes
Assessed at Histology Slides. Intratumoral and stromal infiltrating lymphocyte (TIL) population will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention). This will be used to compute intratumoral and stromal TIL's score, recorded as the percentage of TIL's on the analysed area. Only stromal TIL ́s will be quantified in patients with complete pathological response.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).
Percentage of Tumor Ki67
Assessed at Histology Slides. Ki67 will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention).
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of Cytotoxic T Cells on Peripheral Blood
Flow cytometry will be the method used to assess the number of CD3+CD8+ (cytotoxic T cells) on peripheral blood lymphocytes.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of Natural Killer T Cells on Peripheral Blood
Flow cytometry will be the method used to assess the number of CD3+CD56+ (natural killer T cells) on peripheral blood lymphocytes.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of T Helper Cells on Peripheral Blood
Flow cytometry will be the method used to assess the number of CD3+CD4+ (T helper cells) on peripheral blood lymphocytes.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma IFN-gamma levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine IFN-gamma on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma TNF-alpha levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine TNF-alpha on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Irisin Levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the hormone Irisin on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma SPARC levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein SPARC on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Decorin Levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein Decorin on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Oncostatin M Levels
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine Oncostatin-M on plasma.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Distance traveled in the 10 meter-incremental shuttle walk test
As an indicator of cardiorespiratory fitness, the number of meters that the participant is able to walk/run in the 10 meter-incremental shuttle walk test will be assessed.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal METS reached during a cardiopulmonary exercise test
The participant will be subjected to a maximal incremental conventional cardiopulmonary exercise test on a treadmill. The maximal intensity the participant is able to attain in this assessment will be recorded in METS.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Number of repetitions performed in the 30 second sit-to-stand test
The 30 second sit-to-stand test will be used to assess lower limb dynamic muscular strength. The maximal number of repetitions the participant is able to perform in the 30 second sit-to-stand test will be recorded.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal Isometric Handgrip Strength
The maximal force (in kilograms) the participant is able to produce in an isometric handgrip test will be recorded, using a hand dynamometer.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal Isometric Quadriceps Strength
The maximal force (in kilograms) the participant is able to produce in an isometric strength test for the quadriceps muscle will be recorded using a load cell. Additionally, the time to maximal strength (in seconds) will also be recorded.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours.
Assessed by accelerometry over a period of seven days, the time (in minutes) that the participants spend in light, moderate and vigorous physical activity will be recorded. Additionally, the time (in minutes) spent in sedentary behaviours will also be recorded.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Health-Related Quality of Life
The questionnaires European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (version 1.0) and the Breast 23 Questionnaire (version 1.0) will be implemented to assess cancer-related quality of life. The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Weight
Using bioimpedance, the participants' total body weight, in kilograms, will be assessed with the lightest clothes possible.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Skeletal Muscle Mass
Using bioimpedance, the participants' total body skeletal muscle mass, in kilograms, will be assessed.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Fat
Using bioimpedance, the participants' total body fat, in kilograms, will be assessed.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Body Mass Index
Using weight and height, these parameters will be combined to report BMI in kg/m^2.
Measured: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start31 Jul 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University, Centro Hospitalar de Vila Nova de Gaia/Espinho, Associacao de Investigacao de Cuidados de Suporte em Oncologia, University of Maia
- Responsible party
- Principal investigator, Alberto Alves, University Institute of Maia
- Investigators
- Nuno Rato, MSc, Principal investigator, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976815
- Sponsor's protocol ID
- keymove
- Acronym
- KEYMOVE
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05976815
- Acronym / sponsor ID
- KEYMOVE / keymove
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant Chemotherapy, Physical Exercise, Pathologic Complete Response, Immune System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Collaborators
- Aveiro University, Centro Hospitalar de Vila Nova de Gaia/Espinho, Associacao de Investigacao de Cuidados de Suporte em Oncologia, University of Maia
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 4 Aug 2023 (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.
One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive neoadjuvant chemotherapy alone (standard of care). |
| Experimental Group | Experimental | Behavioral: Combined Aerobic and Resistance ExerciseThe experimental group will receive neoadjuvant chemotherapy (standard of care) in conjunction with an exercise intervention. The exercise intervention will be implemented concurrently for the full duration of the neoadjuvant chemotherapy treatment. |
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)
- being female gender;
- age equals or greater than 18 years old;
- having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
- planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
- being followed by the oncology department of the CHVNG/E;
Key exclusion criteria (3 listed)
- previous cancer diagnostic;
- evidence of synchronous oncologic disease;
- physical or psychiatric contraindication to the practice of physical exercise.
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 |
|---|---|---|
| Combined Aerobic and Resistance ExerciseApart from the neoadjuvant chemotherapy treatment (standard of care), participants allocated to the experimental group will additionally participate in a supervised physical exercise program that comprises 3 weekly sessions during the months that the patient is undergoing chemotherapy treatment. Each 75-minute session will comprise a 10-minute warm up, 30 minutes of strength training involving exercise for the major muscle groups, 30 minutes of aerobic training at 40-89% of heart rate reserve and a 5-minute cool down. | Behavioural | Experimental Group |
Primary outcome
Pathologic Complete Response
Time frame: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.
Pathological response as the primary outcome will be assessed by a blinded pathologist from the tumour surgical specimens after the breast surgery (post-intervention) and will be defined as complete, partial or no response. Besides pathological complete response (defined as ypT0/ypN0), groups will be compared as those with response (complete or partial) versus those with no response. The residual cancer burden which quantifies residual disease after NAC (post-intervention) will also be assessed.
28 secondary outcomes
Treatment Tolerance - clinically assessed.
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Treatment Tolerance - patient reported.
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Chemotherapy Relative Dose Intensity
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Dose Reductions
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Delays
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Number of Chemotherapy Early Discontinuations
Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
Percentage of Tumor Infiltrating Lymphocytes
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).
Percentage of Tumor Ki67
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of Cytotoxic T Cells on Peripheral Blood
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of Natural Killer T Cells on Peripheral Blood
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Percentage of T Helper Cells on Peripheral Blood
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma IFN-gamma levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma TNF-alpha levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Irisin Levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma SPARC levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Decorin Levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Plasma Oncostatin M Levels
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Distance traveled in the 10 meter-incremental shuttle walk test
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal METS reached during a cardiopulmonary exercise test
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Number of repetitions performed in the 30 second sit-to-stand test
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal Isometric Handgrip Strength
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Maximal Isometric Quadriceps Strength
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours.
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Health-Related Quality of Life
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Weight
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Skeletal Muscle Mass
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Total Body Fat
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Body Mass Index
Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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 26 Mar 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.
Alberto Alves, PhD contact
Nuno Rato, MSc principal investigator
University of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Resistance Exercise in people with Breast Cancer, run by University Institute of Maia at 1 site in Portugal.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Mar 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 Portugal. 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.
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 Nuno D Rato, MSc (+351 919985852, nuno.rato@umaia.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (time frame: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.). 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 26 Mar 2025.