sgpgi breast cancer management protocols


SGPGI Breast Cancer protocols have been prepared with the following in mind:

  • Views of Global experts

    • Perception of the local experts and patients

    • Socio-economic, health care logistics in India

  • WHO/MoH guidelines

Department of Endocrine & Breast Surgery
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India

Evidence-Based Pragmatic
SGPGI Breast Cancer Management Protocols (Summary)


Breast cancer management in country like ours with resource limitation and uneven income distribution has to be approached differently from the industrialized world. The stage at disease presentation and pathology are different, so are the socio-economic compulsions of the patients, necessitating emphasis on efficacious, yet safe and cheap management strategies. A pragmatic approach to individual breast cancer patient based on sound scientific evidence, yet keeping the socio-economic realities and infrastructural and manpower compulsions of SGPGI have been worked out over period of many years. Guidelines foprom various professional bodies, meta-analysis, systematic reviews and RCT’s, along with interpretations of contemporary data from faculty and residents of this department as also of collaborating departments of Radiation Oncology, Pathology, Nuclear Medicine and Radio-diagnosis have formed the basis of these guidelines to a large extent. The first formal SGPGI Breast cancer protocols were formulated in late 2001. Since that time, two major revisions have been made. A summary of the third revised version of SGPGI Breast Cancer protocols is provided here.


Clinical presentation of breast carcinoma at SGPGIMS Lucknow include


Breast lump

Usually painless progressive
Occasional nipple discharge
Ulcerated growth

Metastatic symptoms like weight loss, bone pain, jaundice or hemoptysis
Operated elsewhere (various degrees of surgical intervention)
Screen detected (rare)
Patients presenting for hospital based screening, out of concern for cancer usually have-

Breast pain
Breast nodularity
Women with family history

Patients referred for screening/evaluation before or during HRT


Approach to breast lump/suspected breast malignancy


A detailed history including

Number of off-springs and adequacy of breast feeding
Menopausal status, history
Onset, duration and progress of lump
Associated nipple discharge
History of trauma to breast, fever
Use of HRT, OCP
Family history of breast carcinoma, ovarian malignancy and other related tumors in first and second degree relatives,

Diagnostic investigation of a suspected malignancy


Triple test

Clinical breast examination
Fine needle aspiration cytology
Mammography/USG breasts


For patients having prior intervention elsewhere, review of the histology/cytology slides & Blocks.

Based on the above initial workup, a cytologically proven or suspected breast cancer is staged clinically according to the TNM- AJCC 2002* staging system of breast carcinoma

(* Refer to 6th edition of AJCC manual of TNM staging, also available in this course manual in later article)


Clinical stage grouping is done for ease of communication and management planning, as follows:-


Early breast cancer


Small operable tumors (<5 cm), nodal status N0/N1, M0
  Breast conservation possible

Large operable cancers


Large operable tumor (>5 cm), nodal status is N0/N1, M0
  Prognosis is similar to stage II disease




Mastectomy is possible, breast conservation is difficult

Locally advanced breast carcinoma


Mostly stage III disease: T4, N2/ N3, M0
  Considered inoperable, will require neo-adjuvant
  systemic treatment

Metastatic disease


Evidence of metastasis (other than regional lymph nodal metastases)
  Treated with primary systemic treatment/palliative
  measures alone


Investigative work-up after clinical staging:


Following minimal metastatic workup after a working diagnosis and staging is done. In selected patients, other symptoms/signs directed test may be employed-

X ray Chest- PA view
Blood chemistry including serum Alkaline phosphatase, LFT
Mammography if not done earlier.
If >T2 or >N1 disease, symptomatic, raised serum alkaline phosphatase- also include

-99mTc MDP Skeletal Scan
-USG abdomen- to look for metastatic deposits

Clinical staging is upgraded with any added information from imaging.


Treatment protocol for early breast cancer


Early breast cancer- T1/T2, N0/N1, M0 disease

Stage I, IIA, IIB (T2N1)



Treatment protocol for locally advanced breast cancer


Locally advanced (and Large operable) breast cancer- Stage IIIA, IIIB, IIIC, and IIB (T3N0M0)


Treatment protocol for Metastatic Ca Breast:



Chemotherapeutic regimen and agents used commonly:







20mg PO OD

Aromatase inhibitors


2.5mg PO OD

HER 2 monoclonal antibody


4mg/kg loading dose 2mg/Kg/week maintenance till disease progression/1yr/critical toxicity appears


Hormonal agents/targeted therapy used:



Cycle interval




q 21 d


600mg/m2 IV Day 1


60mg/m2 IV Day 1

5 Flurouracil

600 mg/m2 IV Day 1


q 21 d


500mg/m2 IV Day 1


100mg/m2 IV Day 1

5 Flurouracil

500mg/m2 IV Day 1


q 21 d


60mg/m2 IV Day 1


100mg/m2 IV Day 1



q 21 d


100mg/m2 IV Day 1

Doxorubicin/ Epirubicin

50mg/m2 IV Day 1


500mg/m2 IV Day 1


Follow up Protocol

First visit after completing the treatment (Surgery, chemo, and radiotherapy): starts 3 months after completion of treatment or 1 yr after initial evaluation which ever is earlier.

  • Clinical breast examination

  • Hemogram

  • Blood chemistry incl s-ALP, LFT, Ca

  • CA 15-3 (selective)

  • X ray chest

  • ECG/ECHO to r/o CT/RT toxicity

  • Bone mineral densitometry

6 months post treatment:

  • Clinical breast examination

  • Alk PO4

  • X ray chest PA

  • Symptom/chemistry directed tests

1 year after completing initial treatment:

  • Clinical breast examination

  • Blood chemistry incl S Calcium, Alk PO4

  • X ray chest PA

  • Mammogram

  • USG abdomen

  • Tc 99 MDP Bone Scan

Model histology report includes:


Patient name




Central registration number


Side - Left/Right


Date of reporting



Type of specimen

Breast specimen- Wide local excision/Segmental excision/Mastectomy Axillary Specimen- Axillary clearance/Axillary sampling/Sentinel node(s)

Gross Histology

No of lesions/Size of lesion/Site of lesion
No of nodes dissected/grossly significant nodes/Sentinel nodes (no of blue/hot/both blue and hot)


Tumor histology/grade of tumor/vascular or lymphatic invasion/margin status of specimen No of nodes positive/extra-lymphatic spread/sentinel node status


Hormonal receptor (ER/PR)  and HER2neu status


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