Breast CancerPhase 3RESPECTNCT01104935
National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]
A Phase 3 study testing trastuzumab monotherapy and trastuzumab and chemotherapy in people with Breast Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
Trial summary
To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer. Read more about this study
- Who is it for?
- Ages 70 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab monotherapy and trastuzumab and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteJapan
- Study dates
- 28 Oct 2009to 15 Oct 2018
- Phase
- Phase 3
- 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 70 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
- Stage: 1 (tumor size [pT] > 0.5 cm), 2A, 2B or 3A/ M0
- Female between 70 and 80 years old
- Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH
- Baseline left ventricular ejection fraction (LVEF) is ≥55% measured by echocardiography or MUGA scan within 4 weeks before registration.
- PS: 0-1 (ECOG)
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- Sufficient organ function meeting following criteria within 4 weeks before registration:
- Leukocyte ≥2500 mm3
- Neutrophil ≥1500 mm3
- Platelet ≥100 000 mm3
- Serum total bilirubin ≤2.0 x upper limit of normal (ULN)
- ALT (GPT) or AST (GOT) ≤2.5 x ULN
- Serum creatinine ≤2.0 x ULN
- ALP ≤2.5 x ULN
- No previous endocrine therapy or chemotherapy for breast cancer
- Signed written informed consent
Who cannot join
- Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
- Postoperative histological axillary lymph node metastasis ≥4
- Axillary lymph node is not histologically evaluated
- Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
- History of drug-related allergy which could hinder planned treatment
- Any history or complication of following cardiac disorders
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- History of congestive heart failure, cardiac infarction
- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
- Poorly controlled hypertension (ex. Systolic arterial pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg)
- Poorly controlled diabetes
- Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL)
- Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
- Ineligible to the trial based on decision of an investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial
To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.
Read the detailed description
This study is a randomized, comparative trial of postoperative adjuvant therapies in women with HER2 (human epidermal growth factor receptor type-2)-positive primary breast cancer who are ≥70 years of age that will compare trastuzumab (Herceptin®) monotherapy (H group) and trastuzumab in combination with chemotherapy (H+CT group).
The objectives of this study are as follows.
- To verify the clinical positioning of trastuzumab monotherapy and combined trastuzumab and chemotherapy as postoperative adjuvant therapies for the treatment of HER2-positive primary breast cancer patients who are ≥70 years of age.
- To evaluate the safety of trastuzumab monotherapy and combined trastuzumab and chemotherapy in patients who are ≥70 years of age. In particular, to evaluate cardiac disorders that are a characteristic adverse drug reaction of trastuzumab as well as geriatric-related concerns including lipid metabolism, cerebral infarction and cognitive disorders.
- To evaluate overall survival in patients who are ≥70 years of age using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
- To evaluate health-related quality of life (HRQOL), cost-effectiveness (utility), and conduct a comprehensive geriatric assessment (CGA) in patients who are ≥70 years of age and using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
- To establish and expand information networks by the participation of practitioners in clinical trials that are involved in general clinical practice and breast cancer.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab monotherapy, trastuzumab and chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumab monotherapyDrug
Also called Herceptin
trastuzumab and chemotherapyDrug
Also called PTX, DTX, TC, AC
| Study group | Role | What they receive |
|---|---|---|
| trastuzumab monotherapy | Experimental | H group (trastuzumab monotherapy group)
* Trastuzumab: 1-year treatment
* Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times Receives: Drug: trastuzumab monotherapy |
| trastuzumab and chemotherapy | Active comparator | H+CT group (combination therapy of trastuzumab and chemotherapy)
* Chemotherapy: 12 to 24 weeks
* Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC, CMF and TCb (CBDCA)) based on decision of a physician or a patient. Initiate administration of trastuzumab after completion of chemotherapy as a sequential combination. However, concomitant administration is allowed when combining trastuzumab with PTX, DTX and CMF. In cases of TCb (CBDCA), trastuzumab is used concomitant administration. Receives: Drug: trastuzumab monotherapy; Drug: trastuzumab and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease-free survival is defined as the interval from the date of enrollment to the date of any of the following events.
- Local recurrence, distant metastasis
- Metachronous breast cancer, secondary cancer
- Death
Measured: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Secondary outcomes (5)
Overall survival
Overall survival is defined as the interval from the date of enrollment to the date of death from any cause.
Measured: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Relapse-free survival
Relapse-free survival is defined as the interval from the date of enrollment to the date of any of the following events.
- Local recurrence, distant metastasis
- Death
Measured: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Percentage of participants with adverse events as a measure of safety
The following variables are evaluated: left ventricular ejection fraction, white-cell count, neutrophil count, platelet count, bilirubin level, alanine aminotransferase level, aspartate aminotransferase level, alkaline phosphatase level, and creatinine level.
Measured: Evaluations are performed at the time of starting the specified treatment and 2, 6, and 9 month, 1 year, 1 year 6 months, 2 years, 2 years 6 months, and 3 years after the start of treatment. Subsequently, evaluations are done at 1-year intervals.
Health-related QOL (HRQOL)
The following QOL questionnaire forms (in Japanese) are used for evaluations: FACT-G, HADS, EQ-5D, and PNQ.
Measured: Evaluations are performed at the time of starting the specified treatment and 2 months, 1 year, and 3 years after the start of treatment.
Cost effectiveness analysis
Survey items are as follows.
- Direct medical costs: medical costs associated with therapy, the management of adverse events, etc.
- Direct nonmedical costs: transportation expenses required for medical examinations, costs of health foods, etc.
- Indirect costs: work-loss costs associated with treatment that are incurred directly by the patient and by their caregivers
Measured: Data on direct medical costs for the 3-year period after the start of the treatment are obtained from CRF. Data on direct nonmedical costs and indirect costs are obtained from questionnaires 2, 12, and 36 months after starting the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study start28 Oct 2009
- Primary completion31 Oct 2017
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comprehensive Support Project for Oncology Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masataka Sawaki, Principal investigator, Department of Breast Oncology, Aichi Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104935
- Sponsor's protocol ID
- N-SAS BC 07
- Acronym
- RESPECT
- Status last verified
- Jul 2019
- First submitted
- 6 Nov 2009
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nozawa K, Sawaki M, Uemura Y, Tsuneizumi M, Takano T, Gondo N, Hara F, Harao M, Toyama T, Taira N, Vivancos A, Perou CM, Sanfeliu E, Braso-Maristany F, Parker JS, Buckingham W, Pare L, Villacampa G, Marin-Aguilera M, Villagrasa P, Prat A, Iwata H. HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab +/- chemotherapy. Nat Commun. 2025 Nov 4;16(1):9585. doi: 10.1038/s41467-025-65599-x.
PubMed 41188218Hagiwara Y, Sawaki M, Uemura Y, Kawahara T, Shimozuma K, Ohashi Y, Takahashi M, Saito T, Baba S, Kobayashi K, Mukai H, Taira N. Impact of chemotherapy on cognitive functioning in older patients with HER2-positive breast cancer: a sub-study in the RESPECT trial. Breast Cancer Res Treat. 2021 Aug;188(3):675-683. doi: 10.1007/s10549-021-06253-0. Epub 2021 Jun 2.
PubMed 34080094Taira N, Sawaki M, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Ohashi Y, Mukai H, Kawahara T; RESPECT Study Group. Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer. J Clin Oncol. 2021 Aug 1;39(22):2452-2462. doi: 10.1200/JCO.20.02751. Epub 2021 Apr 9.
PubMed 33835842Sawaki M, Taira N, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Kawahara T, Ohashi Y, Mukai H; RESPECT study group. Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients. J Clin Oncol. 2020 Nov 10;38(32):3743-3752. doi: 10.1200/JCO.20.00184. Epub 2020 Sep 16.
PubMed 32936713
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01104935
- Acronym / sponsor ID
- RESPECT / N-SAS BC 07
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Comprehensive Support Project for Oncology ResearchUniversity, hospital or other
- Study start
- 28 Oct 2009 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 16 Apr 2010 (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.
To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.
Detailed description
This study is a randomized, comparative trial of postoperative adjuvant therapies in women with HER2 (human epidermal growth factor receptor type-2)-positive primary breast cancer who are ≥70 years of age that will compare trastuzumab (Herceptin®) monotherapy (H group) and trastuzumab in combination with chemotherapy (H+CT group).
The objectives of this study are as follows.
- To verify the clinical positioning of trastuzumab monotherapy and combined trastuzumab and chemotherapy as postoperative adjuvant therapies for the treatment of HER2-positive primary breast cancer patients who are ≥70 years of age.
- To evaluate the safety of trastuzumab monotherapy and combined trastuzumab and chemotherapy in patients who are ≥70 years of age. In particular, to evaluate cardiac disorders that are a characteristic adverse drug reaction of trastuzumab as well as geriatric-related concerns including lipid metabolism, cerebral infarction and cognitive disorders.
- To evaluate overall survival in patients who are ≥70 years of age using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
- To evaluate health-related quality of life (HRQOL), cost-effectiveness (utility), and conduct a comprehensive geriatric assessment (CGA) in patients who are ≥70 years of age and using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
- To establish and expand information networks by the participation of practitioners in clinical trials that are involved in general clinical practice and breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trastuzumab monotherapy | Experimental | Drug: trastuzumab monotherapyH group (trastuzumab monotherapy group) * Trastuzumab: 1-year treatment * Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times |
| trastuzumab and chemotherapy | Active comparator | Drug: trastuzumab monotherapy, Drug: trastuzumab and chemotherapyH+CT group (combination therapy of trastuzumab and chemotherapy) * Chemotherapy: 12 to 24 weeks * Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC, CMF and TCb (CBDCA)) based on decision of a physician or a patient. Initiate administration of trastuzumab after completion of chemotherapy as a sequential combination. However, concomitant administration is allowed when combining trastuzumab with PTX, DTX and CMF. In cases of TCb (CBDCA), trastuzumab is used concomitant administration. |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
- Stage: 1 (tumor size [pT] > 0.5 cm), 2A, 2B or 3A/ M0
- Female between 70 and 80 years old
- Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH
- Baseline left ventricular ejection fraction (LVEF) is ≥55% measured by echocardiography or MUGA scan within 4 weeks before registration.
Key exclusion criteria (13 listed)
- Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
- Postoperative histological axillary lymph node metastasis ≥4
- Axillary lymph node is not histologically evaluated
- Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
- History of drug-related allergy which could hinder planned treatment
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 |
|---|---|---|
| trastuzumab monotherapyAlso: Herceptin | Drug | trastuzumab and chemotherapy, trastuzumab monotherapy |
| trastuzumab and chemotherapyAlso: PTX, DTX, TC, AC | Drug | trastuzumab and chemotherapy |
Primary outcome
Disease free survival
Time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Disease-free survival is defined as the interval from the date of enrollment to the date of any of the following events. 1. Local recurrence, distant metastasis 2. Metachronous breast cancer, secondary cancer 3. Death
5 secondary outcomes
Overall survival
Time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Relapse-free survival
Time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Percentage of participants with adverse events as a measure of safety
Time frame: Evaluations are performed at the time of starting the specified treatment and 2, 6, and 9 month, 1 year, 1 year 6 months, 2 years, 2 years 6 months, and 3 years after the start of treatment. Subsequently, evaluations are done at 1-year intervals.
Health-related QOL (HRQOL)
Time frame: Evaluations are performed at the time of starting the specified treatment and 2 months, 1 year, and 3 years after the start of treatment.
Cost effectiveness analysis
Time frame: Data on direct medical costs for the 3-year period after the start of the treatment are obtained from CRF. Data on direct nonmedical costs and indirect costs are obtained from questionnaires 2, 12, and 36 months after starting the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 41188218Nozawa K, Sawaki M, Uemura Y, Tsuneizumi M, Takano T, Gondo N, Hara F, Harao M, Toyama T, Taira N, Vivancos A, Perou CM, Sanfeliu E, Braso-Maristany F, Parker JS, Buckingham W, Pare L, Villacampa G, Marin-Aguilera M, Villagrasa P, Prat A, Iwata H. HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab +/- chemotherapy. Nat Commun. 2025 Nov 4;16(1):9585. doi: 10.1038/s41467-025-65599-x.
- Derived from this study: PubMed 34080094Hagiwara Y, Sawaki M, Uemura Y, Kawahara T, Shimozuma K, Ohashi Y, Takahashi M, Saito T, Baba S, Kobayashi K, Mukai H, Taira N. Impact of chemotherapy on cognitive functioning in older patients with HER2-positive breast cancer: a sub-study in the RESPECT trial. Breast Cancer Res Treat. 2021 Aug;188(3):675-683. doi: 10.1007/s10549-021-06253-0. Epub 2021 Jun 2.
- Derived from this study: PubMed 33835842Taira N, Sawaki M, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Ohashi Y, Mukai H, Kawahara T; RESPECT Study Group. Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer. J Clin Oncol. 2021 Aug 1;39(22):2452-2462. doi: 10.1200/JCO.20.02751. Epub 2021 Apr 9.
- Derived from this study: PubMed 32936713Sawaki M, Taira N, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Kawahara T, Ohashi Y, Mukai H; RESPECT study group. Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients. J Clin Oncol. 2020 Nov 10;38(32):3743-3752. doi: 10.1200/JCO.20.00184. Epub 2020 Sep 16.
- Comprehensive Support Project, Public Health Research FoundationLink provided by the sponsor.
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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.
Masataka Sawaki principal investigator
Department of Breast Oncology, Aichi Cancer Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trastuzumab monotherapy and trastuzumab and chemotherapy in people with Breast Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
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 16 inclusion and 13 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: finished, as of the sponsor's last update on 21 Oct 2019. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease free survival (time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104935, which also lists 4 linked publications.
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 21 Oct 2019.