Neoplasms

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Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

   a. all nodes negative: ycN0

   or
2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

   a. only micrometastases in the SN, and no risk factors (grade 3, LVI, tumour size \> 3 cm)

   or
3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

   1. no metastases in the post chemo SN

1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

   a. 1-3 nodes positive: ypN1

   or
2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

   1. micrometastases in the SN and at least 1 risk factor; or
   2. ≤ 2 macrometastases and no risk factor

   or
3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

   1. micrometastases in the post chemo SN and no risk factors (grade 3, LVI, tumour size \> 3 cm)

1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

   a. 4 or more nodes positive: ypN2

   or
2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

   1. ≤ 2 macrometastases in the sentinel node prior to primary systemic treatment in the presence of risk factors like Grade 3, lymphangioinvasion, tumour size \> 3 cm; or
   2. 3 macrometastases, 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases.

   or
3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

   1. Micrometastases in the post chemo SN, and at least one risk factor
   2. ≤ 3 macrometastases in the post chemo SN; or
   3. 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases

after MRM in group 1 (low risk): no radiotherapy after BCT in group 1 (low risk): radiation treatment of the breast with boost (optional)

radiation - no radiation see intervention description

after BCT in group 2 (intermediate risk): radiation treatment of the breast with boost (optional) after MRM in group 2 (intermediate risk): radiation treatment of the thoracic wall If no full ALND is performed in group 2 (intermediate risk) add radiation treatment of level 1 and 2 of the axilla.

radiation: see intervention description

after MRM in group 3 (high risk): radiation treatment of the thoracic wall and supraclavicular nodes after BCT in group 3 (high risk): radiation treatment of the breast with boost (optional) and supraclavicular nodes If no full ALND is performed group 3 (high risk) add radiation treatment of level 1 and 2 of the axilla.

L.J Boersma

A Voogd

R Houben

The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).

Primary systemic treatment for breast cancer patients used to be given only to patients with locally advanced disease. Although until now no studies have been reported that primary systemic treatment leads to a superior survival compared to adjuvant chemotherapy \[Mauri et al, 2005; Mieog et al, 2007\], the last years have been showing an increase in the use of primary systemic treatment , also for patients with earlier stages of breast cancer. The suggested advantages of this policy are 1) that primary systemic treatment allows for monitoring of the response on the treatment, such that the type of chemotherapy can be changed in case of no response, and 2) that primary systemic treatment may shrink the tumour volume, allowing for a higher percentage of breast conserving therapy \[Mieog et al, 2007\]; and 3) the overall 40% chance of converting positive axillary nodes pre-PST to negative, questioning the need for an axillary dissection \[Fontein et al, 2013; Kuehn et al, 2013\]. A major disadvantage of primary systemic treatment is however, that the indications for post-operative radiotherapy are based upon studies where loco-regional recurrences were correlated to the pathological T and N stage in patients who had not been treated with chemotherapy before surgery. Since primary systemic treatment is affecting the pathological T and N stage, the indications for post-operative radiotherapy in these patients have become uncertain.

Objective: The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage). The secondary aim is to develop a risk model based on risk factors, that can be used to predict which of the patients with a cT1-2cN0-1 breast carcinoma, treated with neoadjuvant chemotherapy and surgery, have a 5 yr LRR \> 8 % if radiotherapy is withheld.

Study design: This study is a multicentre prospective cohort study. Study population: In total 710 patients with cT1-2pN0-1, excluding ≥cN2 and patients with \> 3 pathologic axillary nodes on imaging, breast cancer, treated with at least three cycles of chemotherapy followed by breast and axillary surgery are eligible for the study.

During 5 years (2011-2015) patients diagnosed for primary breast cancer and eligible according to the criteria will be registered by the National Cancer Registry in this project.

Currently, three surgical strategies are being followed in cT1-2N0-1 patients, treated with primary systemic treatment :

1. A full axillary lymph node dissection is performed after the primary systemic treatment , OR
2. A sentinel node procedure is carried out prior to neoadjuvant treatment, and no further axillary surgery is performed after chemotherapy, if the patient is clinically node negative (ycN0)), OR
3. A sentinel node procedure is carried out only after primary systemic treatment , in case patient is still/has become clinically node negative (ycN0).

For all three above mentioned strategies, patients are divided into three risk groups, mainly based on the post chemotherapy pathological nodal status (strategy 1 and 3), and on the pre-chemotherapy pathological nodal status and ycN0 status (strategy 2). In addition, for all three strategies the cT and the ycT status are taken into account to choose the recommended guideline.

The radiation treatment guidelines for the subsequent three risk groups consist of:

1. Group I - low risk (N = 237):

   1. after MRM: no radiotherapy
   2. after BCT: radiation treatment of the breast with boost (optional)
2. Group II - intermediate risk (N = 237):

   1. after MRM: radiation treatment of the thoracic wall
   2. after BCT: radiation treatment of the breast with boost (optional)
   3. if no full ALND is performed: add radiation treatment to level 1 and 2
3. Group III - high risk group(N = 237):

   1. after MRM: radiation treatment of the thoracic wall and supraclavicular nodes
   2. after BCT: radiation treatment of the breast with boost (optional), and supraclavicular nodes
   3. if no full ALND is performed (not recommended): add radiation treatment to the axilla level 1 and 2 RT of the axillary (after ALND) and internal mammary chain nodes is optional for group III, based on the local protocol. In case of a positive sentinel node in the internal mammary chain prior to chemotherapy, internal mammary chain irradiation is strongly recommended Main study parameters/endpoints: The primary endpoint is the 5 yr locoregional recurrence rate (LRR). Secondary endpoints are 10 year LRR, 5, 10, and 15 yr relapse free survival rates (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer) and overall survival rates. In addition, analyses will be performed to investigate whether pre-radiotherapy factors (e.g. like age \< 40 yr, response to chemotherapy, tumour size) can be identified that correlate with a high LRR.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Currently no clear data are present in literature showing the indications for radiotherapy in this patient group. Based on literature that is available for patients treated with chemotherapy after surgery we have chosen what we think might be the optimal treatment from a benefit/risk perspective. The study focuses on adequate registration of all risk factors, treatment, and outcome.

Date amendment: 1 July 2013

The main reason for writing an amendment is that current guidelines on axillary treatment are changing, both with respect to surgery and with respect to radiation treatment. Not sufficient data are yet present in literature to define a sound evidence based guideline. However, recent new data strongly suggest that the guidelines should be adapted. Therefore, we adapted the guidelines within the framework of this protocol, with as aim to carefully follow and record the outcome of patients treated with these new guidelines. Whilst writing this amendment, we also used this opportunity to better define "suspicious nodes" on imaging, and to add another very relevant endpoint: relapse free survival.

Radiotherapy After Primary Chemotherapy for Breastcancer

Radiotherapy After Primary CHEMotherapy for cT1-2cN1M0 Breast Cancer.: a Multicentre Prospective Registration Study.

to evaluate the 5 year locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).

to develop a risk model based on risk factors, that can be used to predict which of the patients with a cT1-2cN1 breast carcinoma, treated with neoadjuvant chemotherapy and surgery, have a 5 yr LRR \> 8 % if radiotherapy is withheld.

5 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

10 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

and 15 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

The Netherlands Cancer Institute

Diakonessenhuis, Utrecht

Maastricht Radiation Oncology

ultrasound plus clinical breast examination

all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year

Sun Qiang, MD

Shen Songjie, MD

Sun Qiang, Doctor

Shen Songjie, Doctor

Hongchuan Jiang, MD

Bo Li, MD

Yinhua Liu, MD

Jun Jiang, MD

Yue Shi, MD

Jin Zhang, MD

Yaping Li, MD

Guosheng Ren, MD

Fengming Xie, MD

Zhendong Wang, MD

Mei Sun, MD

Feng Jin, MD

Shuanghu Yuan, MD

Jingjing Yu, MD

Yue Chen, MD

In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to compare the risk evaluation model of PUMCH model which was established by our previous work with other risk models.

Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades. It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, however, our previous study has shown that ultrasound is more sensitive and less expensive than mammography. In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to evaluate the risk model (PUMCH model) which was established by our previous work.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy After Primary Chemotherapy for Breastcancer	NCT01279304	Breast Cancer	radiation - no ... radiation: see ... radiation: see ...	-	Maastricht Radiation Oncology
Radiotherapy After Primary Chemotherapy for Breastcancer	NCT01279304	Breast Cancer	radiation - no ... radiation: see ... radiation: see ...	-	Maastricht Radiation Oncology
Ultrasound-based Breast Cancer Screening in Chinese Women	NCT02268643	Breast Cancer	ultrasound plus...	35 Years - 75 Years	Peking Union Medical College Hospital
Radiotherapy After Primary Chemotherapy for Breastcancer	NCT01279304	Breast Cancer	radiation - no ... radiation: see ... radiation: see ...	-	Maastricht Radiation Oncology
Radiotherapy After Primary Chemotherapy for Breastcancer	NCT01279304	Breast Cancer	radiation - no ... radiation: see ... radiation: see ...	-	Maastricht Radiation Oncology
Ultrasound-based Breast Cancer Screening in Chinese Women	NCT02268643	Breast Cancer	ultrasound plus...	35 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for risk model

Every month we try and update this database with for risk model cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for risk model

Every month we try and update this database with for risk model cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for risk model cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.